At the recent Thermo Fisher Scientific sponsored workshop at the MSACL 2025 conference in Montreal, Canada, Dr. Patrick Vanderboom from Mayo Clinic shared groundbreaking research into the use of extracellular vesicles (EVs) as potential biomarkers for neurodegenerative diseases such as ALS (Amyotrophic Lateral Sclerosis). His team’s work highlights not only the biological promise of EV-based biomarkers, but also the power of complementary mass spectrometry strategies, leveraging deep discovery on the <a target="_blank" rel="noopener noreferrer" href="https://lcms.labrulez.com/products/836">Thermo Scientific Orbitrap Astral mass spectrometer</a> and highly sensitive, multiplexed targeted validation on the <a target="_blank" rel="noopener noreferrer" href="https://lcms.labrulez.com/products/1149">Thermo Scientific Stellar mass spectrometer</a>.&nbsp;Together, these approaches are redefining what is achievable in both discovery and validation proteomics.<img src="https://storage.googleapis.com/labrulez-bucket-strapi-h3hsga3/Thermo_Fisher_Scientific_Breaking_Sensitivity_Barriers_How_MS_is_Transforming_Biomarker_Discovery_for_ALS_and_Beyond_75c7fe8571.jpg" alt="Photo: Thermo Fisher Scientific: Breaking Sensitivity Barriers: How MS³ is Transforming Biomarker Discovery for ALS and Beyond" srcset="https://storage.googleapis.com/labrulez-bucket-strapi-h3hsga3/thumbnail_Thermo_Fisher_Scientific_Breaking_Sensitivity_Barriers_How_MS_is_Transforming_Biomarker_Discovery_for_ALS_and_Beyond_75c7fe8571.jpg 245w," sizes="100vw" width="1024" height="512"><h3>The challenge of sensitivity in biomarker discovery</h3>Detecting disease-relevant proteins from complex, low-abundance samples like cerebrospinal fluid (CSF) or plasma remains a formidable analytical challenge. Even with advanced LC-MS workflows, background noise and insufficient detection sensitivity can obscure critical peptide signals, limiting biomarker validation and reproducibility.Dr. Vanderboom’s team confronted this head-on while developing workflows to identify EV-based ALS-specific markers. Early targeted assays using traditional MS² approaches revealed promising candidates but struggled with low signal intensity and limited reproducibility, clear signs of hitting the sensitivity ceiling.<img src="https://storage.googleapis.com/labrulez-bucket-strapi-h3hsga3/Thermo_Fisher_Scientific_Breaking_Sensitivity_Barriers_How_MS_is_Transforming_Biomarker_Discovery_for_ALS_and_Beyond_2_6be7e53a18.jpg" alt="Thermo Fisher Scientific - Breaking Sensitivity Barriers - How MS³ is Transforming Biomarker Discovery for ALS and Beyond 2.jpg" srcset="https://storage.googleapis.com/labrulez-bucket-strapi-h3hsga3/thumbnail_Thermo_Fisher_Scientific_Breaking_Sensitivity_Barriers_How_MS_is_Transforming_Biomarker_Discovery_for_ALS_and_Beyond_2_6be7e53a18.jpg 208w," sizes="100vw" width="800" height="600"><h3>The MS³ advantage</h3>To overcome these challenges, the Mayo team (pictured above) explored targeted validation on the Stellar MS. Stellar displayed an increase in sensitivity while achieving a fast cycle time, allowing for more points across the peak and increased reproducibility. Several peptides suffered from interfering signal. For these targets, the team explored MS³ (multi-stage fragmentation). By introducing an additional fragmentation and isolation stage, MS³ effectively reduces background interference, producing cleaner spectra and allowing for lower limits of detection.In Vanderboom’s words:“You can see there’s quite a bit of noise in the background, but if you look at that same peptide when we acquired it with MS³, it just cleans up the background. It’s almost like high resolution.”The result? Peptides that were previously undetectable became measurable, enabling discrimination between ALS cases and controls with improved confidence and reproducibility.<h3>From discovery to clinical potential</h3>EVs are a promising new source of biomarkers, but several challenges have limited progress. By leveraging the Obitrap Astral for deep, unbiased discovery using fast DIA with narrow isolation windows, the team identified nearly 6,000 proteins from small EVs in CSF, an unprecedented level of coverage. This expansion in detectable proteome depth represents a critical step toward finding reliable biomarkers that can distinguish ALS from similar neurological conditions.Although state of the art discovery workflows allow for unprecedented depth, confirming targets identified on this platform can be difficult. This is where Stellar comes in. The ability to run highly multiplexed assays with extreme sensitivity, fast LC gradients, and MS³-enabled selectivity allows investigators to fully capitalize on even the most challenging candidate biomarkers.<h3>Conclusion</h3>The incorporation of MS³ workflows on Stellar marks a pivotal evolution in targeted proteomics. As Dr. Vanderboom’s work demonstrates, increasing selectivity while maintaining extreme sensitivity doesn’t just enhance data — it opens new analytical frontiers for diseases where early detection is vital. By combining robust EV isolation with advanced MS³ enabled methods, researchers are now poised to illuminate the molecular signatures of neurodegeneration with unprecedented clarity.Watch the full workshop recording: <a target="_blank" rel="noopener noreferrer" href="https://www.youtube.com/watch?v=lweW3JRr0Ow">Extracellular Vesicle Biomarkers for Neurodegenerative Disease</a><h3>Resources</h3><ul><li>Related blogs in this series → <a target="_blank" rel="noopener noreferrer" href="https://lcms.labrulez.com/article/7480">Accelerating Biomarker Discovery and Validation: From Discovery to Clinical Utility – AnalyteGuru</a></li><li>Other on-demand webinars featuring Stellar → <a target="_blank" rel="noopener noreferrer" href="https://lcms.labrulez.com/webinar/4735">Next-generation workflows for small molecule quantitation using the Thermo Scientific Stellar mass spectrometer</a></li><li>Promotions → <a target="_blank" rel="noopener noreferrer" href="https://www.thermofisher.com/content/lifetech/global/en/home/industrial/mass-spectrometry/mass-spectrometer-price-affordability-programs.html">Mass Spectrometer Affordability Programs | Thermo Fisher Scientific – US</a></li><li>Follow along <a target="_blank" rel="noopener noreferrer" href="https://www.thermofisher.com/content/lifetech/global/en/home/about-us/events/industrial/msacl-us.html">MSACL 2025</a> for more information on Thermo Fisher Scientific participation in MSACL 2026</li><li>Interested in speaking opportunities at future events? Contact <a href="mailto:ema.ruzic@thermofisher.com">Ema Ruzic</a></li></ul><blockquote>Visit us on&nbsp;<a target="_blank" rel="noopener noreferrer" href="https://www.linkedin.com/showcase/72003132/admin/dashboard/">LinkedIn:</a>&nbsp;#Stellar #MayoClinic #Biomarkers #MassSpectrometry</blockquote>

Breaking Sensitivity Barriers: How MS³ is Transforming Biomarker Discovery for ALS and Beyond

The new NIST26 release expands LC-MS/MS data processing with integrated chromatogram analysis and <a target="_blank" rel="noopener noreferrer" href="https://lcms.labrulez.com/products/2462">MS/MS library searching</a>. Within the Chromatogram Window, users can load LC-MS/MS data, configure processing parameters, search spectral libraries, filter results, review identified components, and export selected results for further evaluation.This practical guide is based on James Little’s Processing MS/MS Data in NIST26 Chromatogram Window material from Mass Spec Interpretation Services. It walks through the fundamental workflow for processing MS/MS data in the NIST26 Chromatogram Window, from selecting the appropriate processing mode and input file to library searching, reviewing candidate identifications, and exporting results.<blockquote>👉<a target="_blank" rel="noopener noreferrer" href="https://lcms.labrulez.com/labrulez-bucket-strapi-h3hsga3/Processing_MSMS_Data_in_Chromatogram_Window_NIST_26_09aa3c2996.pdf">Download PDF handout here</a></blockquote><h3>Before You Begin: Navigating the Chromatogram Window</h3>The workflow assumes that users are already familiar with configuring and navigating the NIST26 Chromatogram Window. For new users, the author recommends first reviewing the separate material dedicated to configuring and navigating this environment.NIST26 also provides extensive integrated help. Pressing F1 while working in the Chromatogram Window opens documentation and practical tips for processing tandem MS data. The presentation emphasizes that this help resource contains useful information for understanding individual functions and settings.<h4>1. Set Processing to Tandem Mode</h4>If both EI and tandem NIST software are installed, the first useful step is to specify the type of spectra being processed.<blockquote>In the Chromatogram Window, select: File → Select Spectrum Type → Tandem</blockquote>Selecting Tandem mode simplifies menu navigation and ensures that functions relevant to MS/MS data processing are readily available.<h4>2. Prepare Your Data in mzML Format</h4>For the workflow described in the presentation, NIST26 processes mzML files. Data stored in proprietary instrument formats therefore need to be converted before processing.The presentation recommends using ProteoWizard/msconvert for file conversion.<blockquote>Once the mzML file is available, processing can be started through: File → Analyze MS/MS Input File</blockquote>Select the appropriate mzML file and configure the required processing parameters.<h4>3. Set the Mass Tolerance</h4>Mass tolerance is one of the important parameters used during data processing and spectral matching.The presentation identifies:<ul><li>20 ppm</li><li>40 ppm</li></ul>as reasonable tolerance values.The appropriate setting should ultimately reflect the characteristics of the dataset and instrumentation. These values should therefore be regarded as practical starting points for the demonstrated workflow rather than universal settings for every LC-MS/MS analysis.<h4>4. Select Libraries for Searching</h4>One of the useful features of NIST26 is the ability to search multiple libraries simultaneously.For the type of analysis demonstrated, James Little identifies hr_msms_nist as the preferred library. Depending on the application, users can also work with APCI and low-resolution libraries or free crowd-sourced libraries.Searching several relevant libraries can broaden the identification space, particularly when investigating complex LC-MS/MS datasets.<h4>5. Examine the Initial Results</h4>After processing is complete, the results are displayed directly within the Chromatogram Window. The workspace combines several types of information, including:<ul><li>the chromatogram</li><li>a list of detected components and search results</li><li>information about library hits</li><li>comparison of experimental and library spectra</li><li>proposed compound identity and structural information</li></ul>This layout makes it possible to move quickly from a chromatographic feature to its potential identification and visually evaluate the quality of the spectral match.Abundance can also be displayed using either a linear or logarithmic scale. A logarithmic view can be particularly helpful when the chromatogram contains both highly abundant signals and much weaker components. Pages 6 and 7 of the presentation illustrate the difference between these two views.<h4>6. Save Your Configuration</h4>Once the desired program parameters have been established across the relevant windows, including the Chromatogram Window, it is useful to save the configuration.NIST allows configurations to be saved and restored as *.ini files.This can be particularly valuable when a laboratory uses different processing configurations for different datasets, libraries, or analytical workflows. Instead of manually recreating the settings each time, users can restore a previously saved configuration.According to the presentation, the Save Configuration option is available from the menu in the Lib Search tab.<h5>7. Filter the Results</h5>Initial processing can generate a large number of potential identifications. NIST26 therefore provides several options for filtering and simplifying the results.Functions available from the upper area of the Chromatogram Window include:<ul><li>Best Hits</li><li>Only IDs</li><li>Bkgd</li><li>Filter Scores</li></ul>Changing these filters affects the displayed hit list and the identifications shown in the chromatogram. This allows users to progressively narrow the results and concentrate on components that are most relevant to the analytical task.<h5>Be Careful with the Background Filter</h5>The presentation specifically highlights the Bkgd setting.According to the material, NIST suggests a background setting of approximately 75%, and this is normally useful. However, the author observed a few instances in which applying the background filter removed major peaks despite their good library search scores.These peaks had an XIC value of 0.If an important candidate disappears after applying background filtering, the settings should therefore be reviewed. For these particular peaks, the presentation notes that Bkgd = Any was required.<h4>8. Use Filter Scores with Care</h4>The Filter Scores function provides another way to remove lower-quality spectra from the displayed results.According to the NIST help information cited in the presentation, filtering is based on five quality factors:<ul><li>background</li><li>purity</li><li>max2min</li><li>signal-to-noise</li><li>isotope analysis</li></ul>The filter can be configured to display only identifications above a specified minimum score.The procedure presented is:<ol><li>Turn on Filter Scores above the chromatogram.</li><li>Enter the desired minimum score.</li><li>Select Fixed in the corresponding selection box.</li><li>Only identifications above the specified score will remain visible.</li></ol>The presentation gives 900 as an example setting for obtaining a clear view of the TIC.The author also notes that the practical interpretation of this feature is not necessarily straightforward and recommends experimenting with it to determine whether it is useful for a particular workflow.<h4>9. Sort Results and Create a List of Components of Interest</h4>The results table offers considerable flexibility for organizing potential identifications.Clicking a column header allows the results to be sorted according to the selected parameter. Multiple entries can be selected using Shift or Ctrl together with the left mouse button.Selected entries can then be sent to a smaller list containing only components of interest.The presentation emphasizes that there are many possible approaches to organizing the results. Rather than imposing a single rigid workflow, NIST26 allows users to adapt result selection and review to their specific analytical requirements.<h4>10. Manually Review Candidate Identifications</h4>Automated library searching should not necessarily be treated as the final step in compound identification. Once a list of relevant components has been created, the presentation recommends reviewing the candidates individually.A practical approach is to:<ol><li>Sort the results by RT (retention time).</li><li>Left-click the first hit to highlight it.</li><li>Use the up and down arrow keys to move through the list.</li><li>Carefully inspect the spectral comparison for every candidate.</li><li>Decide whether each identification should be included in the final report.</li></ol>An important tool for this review is the butterfly display in the upper-right portion of the workspace. It provides a visual comparison of the measured and reference spectra.Combining automated search scores with expert examination of the spectral match provides a more considered approach to reviewing proposed identifications.<h4>11. Export Selected Results to Excel</h4>Once the relevant identifications have been reviewed, selected results can easily be transferred into a spreadsheet.Highlight the desired entries, right-click, and choose:Copy Selected Hits to ClipboardThe copied information can then be pasted directly into Microsoft Excel.This provides a convenient way to create a customized results table for further evaluation, documentation, or preparation of an analytical report. The workflow is illustrated on page 13 of the presentation.<h4>12. Perform a More Detailed Review with the XIC Browser</h4>For candidate identifications requiring further investigation, the corresponding spectrum can be sent to the XIC Browser/XIC Analyzer.<blockquote>From the selected result, right-click and choose: Send To → XIC Analyzer</blockquote>This opens a more detailed view of the MS/MS data.The example on page 14 demonstrates how the isotope pattern can support an identification involving two chlorine atoms. The XIC Browser also provides MS1 information underlying the MS2 spectrum, adding another layer of information for evaluating a candidate.As with the main Chromatogram Window, users can press F1 or access Help for more detailed information about the XIC Browser and its functions.<h4>Recommended NIST26 Workflow</h4><blockquote>The overall procedure can be summarized as:mzML data → Tandem mode → mass tolerance settings → MS/MS library selection → data processing → result filtering → selection of relevant components → manual spectral review → XIC review → export of results</blockquote>A key advantage of the NIST26 Chromatogram Window is its flexibility. Users do not have to accept every automatically proposed identification. Instead, results can be filtered, sorted, organized into custom lists, and individually reviewed before being included in the final report.<h3>Conclusion</h3>The NIST26 Chromatogram Window provides a more integrated environment for processing LC-MS/MS data and performing spectral library searches. The workflow presented by James Little begins with mzML data and appropriate Tandem mode configuration, followed by library selection, processing, filtering, and systematic review of candidate identifications.An important principle is not to rely exclusively on automated scores. Filters can help transform a large results set into a manageable list of candidates, but final evaluation should also consider spectral comparisons, chromatographic information, and, where appropriate, additional examination in the XIC Browser.The ability to save processing configurations and export selected results to Excel further supports the development of practical and repeatable workflows for routine LC-MS/MS data processing.

Processing MS/MS Data in NIST26 Chromatogram Window

In September 2026, Prague will become a global meeting point for the chromatography community. From 6 to 10 September 2026, the city will host the <a target="_blank" rel="noopener noreferrer" href="https://lcms.labrulez.com/events/644">35th International Symposium on Chromatography – ISC 2026</a>, one of the leading international events dedicated to chromatography, separation science, and analytical chemistry.Shimadzu is proud to support this prestigious event as a Platinum Sponsor.<img src="https://storage.googleapis.com/labrulez-bucket-strapi-h3hsga3/ISC_2026_Shimadzu_as_a_platinum_sponsor_mensi_8c9f3eb6e7.jpg" alt="ISC 2026: Platinum sponsor Shimadzu" srcset="https://storage.googleapis.com/labrulez-bucket-strapi-h3hsga3/thumbnail_ISC_2026_Shimadzu_as_a_platinum_sponsor_mensi_8c9f3eb6e7.jpg 235w," sizes="100vw" width="1600" height="1066">ISC 2026 represents a unique opportunity for scientists, researchers, industry experts, application specialists, and technology providers to meet, exchange knowledge, and discuss the latest developments in chromatography and separation science. The conference will bring together experts from academia, pharmaceutical industry, environmental analysis, food safety, healthcare, life sciences, and many other fields where analytical technologies play an essential role.We would like to warmly invite our customers, partners, colleagues, and the wider scientific community to join us at ISC 2026 in Prague. The conference will offer an inspiring scientific programme, lectures by internationally recognised experts, dedicated sessions on current trends and challenges, an exhibition area, and valuable opportunities for networking with the global chromatography community.Following the successful <a target="_blank" rel="noopener noreferrer" href="https://lcms.labrulez.com/events/642">ISC 2024 in Liverpool</a>, ISC 2026 will bring this important international symposium to the heart of Europe. We are looking forward to meeting you in Prague and contributing together to a strong and successful edition of ISC.<img src="https://storage.googleapis.com/labrulez-bucket-strapi-h3hsga3/1728218963766_9d5394a9da.jpg" alt="Gesa Schad: Shimadzu at ISC 2024 in Liverpool" srcset="https://storage.googleapis.com/labrulez-bucket-strapi-h3hsga3/thumbnail_1728218963766_9d5394a9da.jpg 156w," sizes="100vw" width="1280" height="1280">Visit <a target="_blank" rel="noopener noreferrer" href="https://lcms.labrulez.com/events/1371">Shimadzu at ISC 2026</a> in Prague and be part of one of the key international events in chromatography and separation science.<blockquote>Registration is open on the official conference website: <a target="_blank" rel="noopener noreferrer" href="https://www.isc2026.org">www.isc2026.org</a></blockquote><h3>Shimadzu Vendor Seminar: Three New Reasons to Rethink Your Workflow</h3><ul><li>07 September 2026</li><li>12 PM - &nbsp;13 PM</li></ul>Join us for an engaging seminar introducing three new analytical solutions designed to help laboratories work smarter, respond faster, improve robustness, and achieve greater confidence in their results. As analytical demands continue to grow, laboratories need technologies that not only deliver strong performance, but also enhance efficiency, flexibility, and ease of operation. This seminar will highlight how our latest innovations in IC, UHPLC, and GC-MS/MS can streamline workflows, support complex applications, and create new opportunities for productivity across your laboratory.<h5><a target="_blank" rel="noopener noreferrer" href="https://lcms.labrulez.com/library?mainauthorItems=1&amp;search=nexera+ic">Nexera IC</a> – New compact ion chromatography solution for reliable, high-sensitivity anion and cation analysis.</h5><ul><li>Dr. Gesa Schad</li></ul><h5><a target="_blank" rel="noopener noreferrer" href="https://lcms.labrulez.com/library?mainauthorItems=1&amp;search=nexera+x4">Nexera X4</a> – Next-generation UHPLC platform designed for ultra-high performance and robust operation without compromise.</h5><ul><li>Dr. Gesa Schad</li></ul><h5><a target="_blank" rel="noopener noreferrer" href="https://gcms.labrulez.com/labrulez-bucket-strapi-h3hsga3/c146_e517_16e9bfd835.pdf">GCMS-TQ RX Series</a> – Advanced triple quadrupole GC-MS/MS systems engineered for enhanced sensitivity and dependable trace-level analysis.</h5><ul><li>Dr. Waldemar Weber</li></ul><blockquote><a target="_blank" rel="noopener noreferrer" href="https://www.shimadzu.eu/forms/vendor-seminar-registartion_isc2026.html">Register here to attend Shimadzu Vendor Seminar</a></blockquote><h3>Scientific Programme Presentation</h3><ul><li>08 September 2026</li><li>10:30 – 12:00</li><li>Fun 5: Separations with Supercritical and Subcritical Fluids&nbsp;</li></ul><h5>Accelerating Forensic Analysis: A Rapid SFC-MS Workflow for Novel Regioisomeric Fluorofentanyl Derivatives and Related Compounds</h5><ul><li>Dr. Jennifer Field, Shimadzu UK, Milton Keynes, UK</li></ul><h3>Winners of the Shimadzu student sponsorship</h3>We are thrilled to announce the winners of the Shimadzu student sponsorship for free tickets to attend the ISC 2026 conference. We received a great number of high-quality abstracts, showcasing the innovative research being conducted by students all over Europe.We extend our heartfelt congratulations to all the winners and look forward to their contributions at the conference. To those who were not selected this time, we encourage you to continue your excellent work and apply again in the future.And the lucky winners are: &nbsp; &nbsp;<h5>Chromatography supports electrochemistry–mass spectrometry (EC-MS) analysis of olaparib and inavolisib metabolites</h5><ul><li>Fabiola Dontsi Tonleu, University of Münster, Germany&nbsp;</li><li>Abstract ID: ISC-0262 &nbsp; &nbsp;</li></ul><h5>Towards circular wind energy: Sample preparation strategies in combination with GC×GC-TOFMS for the characterization of wind turbine blade recycling products&nbsp;</h5><ul><li>Giulia Giacoppo, University of Ferrara, Italy</li><li>Abstract ID: ISC-0169 &nbsp; &nbsp;</li></ul><h5>Implementing SFC for analysis of antibiotics in manure</h5><ul><li>Michelle Hussock, University of Duisburg-Essen, Germany</li><li>Abstract ID: ISC-0220 &nbsp;</li></ul><h5>Identifying optimal LC-MS conditions for oligonucleotide mapping of mRNA: A multi-criteria assessment of methods</h5><ul><li>Athanasios Tsalmpouris, University of Geneva, Switzerland</li><li>Abstract ID: ISC-0211</li></ul><h5>From weeds to crop protectants: phytochemical profiling and dual biopesticidal activities of Chenopodium ambrosioides and Cleome gynandra &nbsp;</h5><ul><li>Rahim Ullah, University of Helsinki, Finland</li><li>Abstract ID: ISC-0249 &nbsp;</li></ul><h4>Poster Presentations</h4><h5>Optimal column selection for experimental surface polarity measurement using supercritical fluid chromatography</h5><ul><li>Yoshiyuki Watabe, Shimadzu Corporation, Kyoto, Japan</li><li>Session: BIO08 - Sample preparation and automation</li></ul><h5>Characterization of SFC stationary phases for Analysis of Essential Oils</h5><ul><li>Martin Meyer, Shimadzu Europa, Duisburg, Germany</li></ul><h5>High-sensitivity analysis of more than 100 pesticides in food using microflow LC-MS/MS</h5><ul><li>Ramy Abou Naccoul, Shimadzu France, Marne la Vallée, France</li><li>Session: HYP05 - Microfluidic and chip separations in MS</li></ul><h5>Streamlined selection of optimal separation conditions using an automated LC/SFC method development platform</h5><ul><li>Dr. Gesa Schad, Shimadzu Europa, Duisburg, Germany</li><li>Session: FUN05 - Separations with super - and sub-critical fluids</li></ul><h5>Ion Chromatographic Determination of Major Inorganic Ions in Beer for Quality Control and Product Differentiation</h5><ul><li>Dr. Vadim Kraft, Shimadzu Europa, Duisburg, Germany</li><li>Session: FUN08 - Separation modes</li></ul><h5>Efficient SFC Method Development for the Analysis of Essential Oils Using Shimadzu LabSolutions MD</h5><ul><li>Dr. Brigitte Bollig, Shimadzu Europa, Duisburg, Germany</li><li>Session: HYP02 - SFC-MS</li></ul><h5>Assessing the applicability of retention modelling as a tool for oligonucleotide analysis using ion-pair HPLC</h5><ul><li>Richard Hodgson, Shimadzu UK, Milton Keynes, UK</li></ul><h3><a target="_blank" rel="noopener noreferrer" href="https://lcms.labrulez.com/article/7477">ISC 2026 Scientific program</a> highlights</h3>The programme runs across three parallel tracks — Fundamentals, Bioanalysis &amp; Omics Applications, and Hyphenation Techniques — covering topics from column technology, chiral and multi-dimensional separations, and AI/machine learning in separation science, to proteomics, green analytical chemistry, and LC/MS data processing.<h4>Why it matters for industry</h4>This year's Industry Program is shaping up particularly well, giving companies a direct space to connect with academia and the next generation of scientists:<ul><li>Industry &amp; Education – bridging academic training with industry needs</li><li>Career Presentation – companies showcase career paths and hiring needs to students and professionals</li><li>AI in Separation Science – real-world use of AI in method development and lab workflows</li><li>Sustainability in Separation Science – translating green chemistry research into industrial practice</li></ul>

Shimadzu to Join ISC 2026 in Prague as Platinum Sponsor

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Shimadzu Corporation is a global technology company founded in Kyoto, Japan, in 1875. Guided by its philosophy of “Contributing to Society through Science and Technology,” Shimadzu develops advanced analytical and measuring instruments, medical systems, industrial machinery, and other technologies supporting research, healthcare, industry, and society worldwide.

SHIMADZU CORPORATION

My main interest is the identification of organic compounds by mass spectrometry in organic mixtures.

James Little/Mass Spec Interpretation Services

Identification of the proteins (Bioanalytic)

We perform proteomic analyses on a state-of-the-art high-resolution ZenoTOF 7600 (SCIEX), in which the Zeno ion trap and EAD (Electron-Activated Dissociation) technology together make a powerful combination.

Protein identification is based on experimental measurement of peptide molecular weights and matching the amino acid sequence of the protein under study with protein sequences deposited in libraries (databases). Two approaches are most commonly used in proteomic studies: top-down and bottom-up. The top-down method involves analyzing full protein sequences. Bottom-up analyses, on the other hand, use digestion of proteins with proteolytic enzymes. The peptides obtained by digestion are analyzed using a mass spectrometer. Each analysis leads to a comparison of experimental data with data obtained by theoretical digestion of proteins described in the database.<img src="https://storage.googleapis.com/labrulez-bucket-strapi-h3hsga3/Bioanalytic_Identification_of_the_proteins_Bioanalytic_2_6231b73f0d.jpg" alt="Bioanalytic: Identification of the proteins." srcset="https://storage.googleapis.com/labrulez-bucket-strapi-h3hsga3/thumbnail_Bioanalytic_Identification_of_the_proteins_Bioanalytic_2_6231b73f0d.jpg 245w," sizes="100vw" width="1536" height="766"><h4>LC-MS/MS</h4>Tandem mass spectrometers are commonly used to determine protein sequences. They allow ion selection of pseudomolecular peptides and then fragmentation and measurement of the masses of the resulting fragments. Fragmentation using collision induced dissociation(CID ) is an invaluable tool in targeted and untargeted MS/MS analysis of small molecules. It is important to note that in proteomic analysis, data obtained using the aforementioned fragmentation method may leave gaps. For example, spectra obtained by CID fragmentation do not allow unambiguous differentiation of some amino acids: leucine from isoleucine (identical molar masses and CID fragmentation) and lysine from glutamine (very similar masses). For this reason, we perform proteomic analyses on a state-of-the-art high-resolution <a target="_blank" rel="noopener noreferrer" href="https://lcms.labrulez.com/library?manufacturerItems=52&amp;search=+ZenoTOF+7600">ZenoTOF 7600</a> (SCIEX), in which the Zeno ion trap and EAD (Electron-Activated Dissociation) technology together make a powerful combination. It enables the creation of unique fragments to differentiate problematic amino acids and increase the sensitivity and specificity of the analysis.<blockquote>We perform analyses of:<ul><li>samples from solution;</li><li>samples from a gel;</li><li>samples from a complex matrix (by prior arrangement);</li><li>samples from lyophilizer;</li><li>samples previously prepared by the client.</li></ul>Qualitative analysis of proteins includes:<ul><li>To confirm the presence of a protein, the sample is subjected to digestion and the result obtained from experimental data is compared with theoretical data;</li><li>Comparison of experimental data on the masses of peptides included in the analyzed protein with the protein sequences described in the database;</li><li>Analysis and identification of the protein mixture;</li><li>Identification of post translational modifications (PTMs) (we use the tools: Skyline, Spectronaut).</li><li>Reporting of the result including, but not limited to, confirmation of the coverage of the protein sequence obtained in the test sample with the theoretical protein and the list of modified peptides, location and % of modifications.</li></ul>Comparative analyses include:<ul><li>Determining the composition of mixtures;</li><li>Comparison and profiling of sample series - protein identification and trend analysis.</li></ul>Our offer also includes:<ul><li>Support in the planning and execution of studies (the scope is determined individually);</li><li>Assistance in the development of extraction methods from complex matrices - biological fluids, plant tissue, animal tissues (the scope is determined individually);</li><li>Statistical analysis using tools: MarkerView (PCA), GraphPad Prism, Trends, Sciex OS;</li><li><a target="_blank" rel="noopener noreferrer" href="https://lcms.labrulez.com/products/1294">Quantitative analysis of proteins</a>;</li><li><a target="_blank" rel="noopener noreferrer" href="https://lcms.labrulez.com/products/1296">Analysis and characterization of monoclonal antibodies</a>.</li></ul></blockquote><img src="https://storage.googleapis.com/labrulez-bucket-strapi-h3hsga3/Bioanalytic_Identification_of_the_proteins_Bioanalytic_1_97cf8c94b3.jpg" alt="Bioanalytic: Identification of the proteins." srcset="https://storage.googleapis.com/labrulez-bucket-strapi-h3hsga3/thumbnail_Bioanalytic_Identification_of_the_proteins_Bioanalytic_1_97cf8c94b3.jpg 117w," sizes="100vw" width="1500" height="2000">

Common GLP-1 Peptide Blind Test (Semaglutide, Tirzepatide and Retatrutide)

Blind HPLC analysis of semaglutide, tirzepatide and retatrutide. Identify the peptide, determine its amount and purity, and choose from a range of additional laboratory analyses.

The Common GLP-1 Peptide Blind Test is a comprehensive laboratory analysis designed to identify the three most common GLP-1 peptides—semaglutide, tirzepatide, and retatrutide. Using HPLC, the test identifies the peptide present in the sample, accurately measures its amount, and determines peptide purity. If multiple target peptides are present, all detected compounds are identified and quantified.Because this is a blind analysis, there is no need to specify which peptide is expected in the sample before submission.<h3>About the Target Peptides</h3>Semaglutide is a long-acting GLP-1 receptor agonist widely used for the treatment of type 2 diabetes and obesity. Its prolonged activity improves glycemic control while promoting weight loss.Tirzepatide is a dual GIP and GLP-1 receptor agonist that combines two incretin pathways, providing enhanced metabolic effects compared to conventional GLP-1 therapies.Retatrutide is a next-generation triple agonist targeting GLP-1, GIP, and glucagon receptors. It is currently under clinical investigation as a promising therapy for obesity and metabolic disorders.<h4>Key Features</h4><ul><li>Blind identification of semaglutide, tirzepatide, or retatrutide</li><li>Identification of mixtures containing multiple GLP-1 peptides</li><li>Quantification of peptide content</li><li>Peptide purity determination</li><li>HPLC analytical method</li><li>Results reported in mg per vial for lyophilized samples</li><li>Optional m/m purity reporting</li><li>Suitable for lyophilized peptides and raw API powders</li><li>Average turnaround time of 7 business days</li></ul><h4>Analysis Parameters</h4><ul><li>Target compounds: Semaglutide, Tirzepatide, Retatrutide</li><li>Testing method: HPLC</li><li>Detection limit: Less than one twentieth of a standard vial dosage</li><li>Result format (lyophilizate): mg per vial and peptide purity</li><li>Alternative format: m/m purity and peptide purity</li><li>Minimum sample (lyophilizate): One unopened vial</li><li>Minimum sample (raw API): 30 mg in sealed glass vial</li></ul><blockquote>Important Notice: If multiple GLP-1 peptides are present in the same sample, individual peptide purity may not be measurable.</blockquote><h4>Optional Additional Analyses</h4>The following optional laboratory services are available:<ul><li>GLP-1 aggregate analysis</li><li>Trifluoroacetic acid (TFA) analysis</li><li>Complete raw analytical data</li><li>Fentanyl screening</li><li>Batch variance testing</li><li>pH measurement</li><li>Endotoxin (LPS) analysis</li><li>CHNS mass report</li><li>Additional laboratory report</li><li>LC/MS peptide contamination screening</li><li>Sterility testing (TAMC/TYMC)</li><li>Heavy metals analysis (As, Cd, Pb, Hg)</li></ul>

Blind common anabolic steroid and aromatase inhibitors screening – orals (pills, tablets, capsules)

Blind HPLC screening of common anabolic steroids and aromatase inhibitors in pills, tablets, and capsules. The analysis identifies and quantifies all detected target compounds, including mixtures.

The Blind Common Anabolic Steroid and Aromatase Inhibitor Screening is a comprehensive laboratory analysis designed to detect and quantify commonly encountered anabolic-androgenic steroids and aromatase inhibitors in oral products - pills, tablets, and capsules.Because this is a blind analysis, there is no need to specify which substance is expected in the sample before submission. Every target compound included in the screening is assessed, and all detected substances are identified and quantified, including samples containing mixtures of multiple compounds.<h4>About the Target Compounds</h4>Anabolic-androgenic steroids are synthetic derivatives of testosterone or related steroid hormones. They interact with androgen receptors and have both anabolic effects, associated with tissue and muscle growth, and androgenic effects. The screened compounds include substances such as oxandrolone, stanozolol, oxymetholone, methandrostenolone, fluoxymesterone, methasterone, mesterolone, methenolone acetate, and 4-chlorodehydromethyltestosterone. Individual compounds differ considerably in their chemical structure, potency, metabolism, and relative anabolic and androgenic activity.Letrozole, anastrozole, and exemestane are aromatase inhibitors. They inhibit aromatase, the enzyme involved in estrogen biosynthesis, thereby reducing estrogen production. Letrozole and anastrozole are non-steroidal aromatase inhibitors, whereas exemestane is a steroidal aromatase inhibitor. These substances are used medically in hormone-sensitive breast cancer treatment but may also be found in products associated with anabolic steroid use.<h4>Key Features</h4><ul><li>Blind screening with no need to declare the expected compound</li><li>Detection of common anabolic steroids and aromatase inhibitors in oral dosage forms</li><li>Identification of mixtures containing multiple target compounds</li><li>Quantification of every detected target compound</li><li>Suitable for pills, tablets, and capsules</li><li>Results reported in mg per pill, tablet, or capsule</li><li>HPLC analytical method</li><li>Average turnaround time of 7 business days</li></ul><h4>Analysis Parameters</h4><ul><li>Target compounds: Letrozole, anastrozole, exemestane, fluoxymesterone, methandrostenolone, oxandrolone, stanozolol, 4-chlorodehydromethyltestosterone, mesterolone, methenolone acetate, methasterone, and oxymetholone</li><li>Other common names and brand names: Femara, Arimidex, Aromasin, Halotestin, Halo, Anavar, Var, Winstrol, Winny, Turinabol, Tbol, Proviron, Superdrol, Anadrol, Anapolon, Methandienone, Dianabol, and Dbol</li><li>Testing method: HPLC</li><li>Detection limit cutoff:&nbsp;<ul><li>2 mg per pill / tablet / capsule</li><li>Letrozole and anastrozole: 0.2 mg pill / capsule</li></ul></li><li>Result format: mg per pill / tablet / capsule</li><li>Minimum sample amount: One pill / tablet / capsule</li><li>Optimal sample amount: Three pills / tablets / capsules</li><li>Average turnaround time: 7 business days</li></ul><h4>Optional Additional Analyses</h4>The following optional laboratory services are available:<ul><li>Complete Raw Analytical Data</li><li>Batch Variance Testing</li><li>GC–MS Contamination Screening</li><li>Fentanyl Screening</li><li>Heavy Metals Analysis (As, Cd, Pb, Hg)</li><li>Additional Laboratory Report</li></ul>

Blind common anabolic steroid and aromatase inhibitors screening – raws

Blind HPLC screening of common anabolic steroids and aromatase inhibitors in raw API powders. The analysis identifies the target compound and determines its percentage content.

The Blind Common Anabolic Steroid and Aromatase Inhibitor Screening is a comprehensive laboratory analysis designed to identify and quantify commonly encountered anabolic-androgenic steroids and aromatase inhibitors in raw active pharmaceutical ingredient (API) powders.Because this is a blind analysis, there is no need to specify which substance is expected in the sample. The analysis screens for all target compounds listed below and identifies and quantifies any detected substance.<h4>About the Target Compounds</h4>Anabolic-androgenic steroids are synthetic derivatives of testosterone or structurally related steroid hormones. They interact with androgen receptors and produce both anabolic effects, associated with tissue and muscle growth, and androgenic effects. The screening covers testosterone and nandrolone esters, trenbolone derivatives, drostanolone esters, boldenone undecylenate, trestolone acetate, dihydroboldenone cypionate, and several other commonly encountered anabolic steroids.Esterification modifies properties such as solubility and the rate at which a steroid is released after administration. For this reason, the panel includes multiple ester forms of testosterone, trenbolone, nandrolone, drostanolone, methenolone, and other steroid compounds.Letrozole, anastrozole, and exemestane are aromatase inhibitors. They inhibit aromatase, the enzyme involved in estrogen biosynthesis, thereby reducing estrogen production. Letrozole and anastrozole are non-steroidal aromatase inhibitors, whereas exemestane is a steroidal inhibitor.<h4>Key Features</h4><ul><li>Blind screening with no need to declare the expected compound</li><li>Identification of common anabolic steroids and aromatase inhibitors in raw API powders</li><li>Broad panel covering steroid bases, esters, and aromatase inhibitors</li><li>Quantification of the detected target compound</li><li>Analysis by HPLC</li><li>Results reported as percentage content</li><li>Average turnaround time of 7 business days</li><li>Minimum sample amount of 200 mg of raw powder</li></ul><h4>Analysis Parameters</h4><ul><li>Target compounds: testosterone propionate, testosterone phenylpropionate, testosterone isocaproate, testosterone enanthate, testosterone cypionate, testosterone decanoate, trenbolone base, trenbolone acetate, trenbolone enanthate, trenbolone hexahydrobenzylcarbonate, trestolone acetate, nandrolone phenylpropionate, nandrolone decanoate, drostanolone propionate, drostanolone enanthate, dihydroboldenone cypionate, boldenone undecylenate, letrozole, anastrozole, dihydrotestosterone (DHT), exemestane, fluoxymesterone, methandrostenolone, oxandrolone, stanozolol, 4-chlorodehydromethyltestosterone, mesterolone, methasterone, oxymetholone, methenolone acetate, methenolone enanthate, and testosterone base</li><li>Other common names and brand names: Andriolos, Parabolan, MENT, NPP, Deca, BU, Equipoise, EQ, Parenabol, Femara, Arimidex, Aromasin, Halotestin, Halo, Anavar, Var, Winstrol, Turinabol, Proviron, Anadrol, Anapolon, Primobolan, Test E, Test C, Methandienone, Dianabol, and Dbol</li><li>Testing method: HPLC</li><li>Detection limit cutoff: 50%</li><li>Result format: % [98%+, 96%+ or % value such as 94.15%]</li><li>Minimum sample amount: 200 mg of raw powder</li><li>Average turnaround time: 7 business days</li></ul><blockquote>Important Notice: The detection cutoff is 50%. Samples containing a target compound below this level may therefore fall outside the standard scope of the screening.</blockquote><h4>Optional Additional Analyses</h4>The following optional laboratory services are available:<ul><li>Complete Raw Analytical Data</li><li>Fentanyl Screening</li><li>GC–MS Contamination Screening</li><li>Heavy Metals Analysis (As, Cd, Pb, Hg)</li><li>Additional Laboratory Report</li></ul>

Blind common anabolic steroid screening – ID only

Blind HPLC identification of common anabolic steroids and selected aromatase inhibitors in oils, oral products, and raw API powders. The analysis reports the detected compound without quantification.

The Blind Common Anabolic Steroid Screening – ID Only is a laboratory analysis designed to identify commonly encountered anabolic-androgenic steroids and selected aromatase inhibitors in an unknown sample. The test is suitable for oil-based samples, oral dosage forms such as tablets and capsules, and raw active pharmaceutical ingredient (API) powders.Because this is a blind analysis, there is no need to specify which substance is expected in the sample. The analysis screens for all target compounds listed below and reports the identity of the detected compound.<h4>About the Target Compounds</h4>Anabolic-androgenic steroids are synthetic derivatives of testosterone or structurally related steroid hormones. They interact with androgen receptors and produce both anabolic effects, associated with tissue and muscle growth, and androgenic effects.The analysis covers testosterone, trenbolone, nandrolone, drostanolone, methenolone, boldenone, and other commonly encountered anabolic steroids. It includes both non-esterified steroid bases and esterified forms, which differ in properties such as solubility and release rate after administration.The screening also includes letrozole, anastrozole, and exemestane. These compounds are aromatase inhibitors that reduce estrogen production by inhibiting the aromatase enzyme. Letrozole and anastrozole are non-steroidal inhibitors, whereas exemestane is a steroidal aromatase inhibitor.<h4>Key Features</h4><ul><li>Blind identification with no need to declare the expected compound</li><li>Identification of common anabolic steroids and selected aromatase inhibitors</li><li>Suitable for oil-based samples, tablets, capsules, and raw API powders</li><li>Broad selection of steroid bases and esterified compounds</li><li>Analysis by HPLC</li><li>Results reported as the name of the detected compound</li><li>Average turnaround time of 7 business days</li><li>Minimum sample requirements adapted to the submitted sample type</li></ul><h4>Analysis Parameters</h4><ul><li>Target compounds: testosterone propionate, testosterone phenylpropionate, testosterone isocaproate, testosterone enanthate, testosterone cypionate, testosterone decanoate, trenbolone base, trenbolone acetate, trenbolone hexahydrobenzylcarbonate, trestolone acetate, nandrolone phenylpropionate, nandrolone decanoate, drostanolone propionate, drostanolone enanthate, dihydroboldenone cypionate, boldenone undecylenate, letrozole, anastrozole, exemestane, fluoxymesterone, methandrostenolone, oxandrolone, stanozolol, 4-chlorodehydromethyltestosterone, mesterolone, methasterone, oxymetholone, methenolone acetate, methenolone enanthate, and testosterone base</li><li>Testing method: HPLC</li><li>Result format: Name of the AAS found in the sample</li><li>Minimum sample amount&nbsp;<ul><li>oils: 0.5–1 mL</li><li>oral products: One tablet or capsule</li><li>raw powders: 200 mg</li></ul></li><li>Average turnaround time: 7 business days</li></ul><blockquote>Important Notice: This analysis provides compound identification only. The amount, concentration, or percentage content of the detected substance is not measured.</blockquote><h4>Optional Additional Analyses</h4>The following optional laboratory services are available:<ul><li>Fentanyl Screening</li><li>GC–MS Contamination Screening</li><li>Heavy Metals Analysis (As, Cd, Pb, Hg)</li><li>Additional Laboratory Report</li></ul>

DHT enanthate analysis

Targeted HPLC analysis of DHT enanthate in oil-based samples and raw API powders. The test confirms compound identity and determines its content in mg/mL or percentage.

The DHT Enanthate Analysis is a targeted laboratory test designed to confirm the identity and determine the amount of dihydrotestosterone enanthate in oil-based samples and raw active pharmaceutical ingredient (API) powders.The analysis specifically targets DHT enanthate. Samples expected to contain non-esterified DHT should instead be submitted for the appropriate blind common anabolic steroid screening for <a target="_blank" rel="noopener noreferrer" href="https://lcms.labrulez.com/products/2478">oils </a>or<a target="_blank" rel="noopener noreferrer" href="https://lcms.labrulez.com/products/2476"> raw API powders</a>.<h4>About DHT Enanthate</h4>DHT enanthate, also known as dihydrotestosterone heptanoate, is an esterified form of DHT designed for slower release and potentially prolonged activity. The enanthate group increases the compound’s lipophilicity. After release, DHT activates androgen receptors and, unlike testosterone, cannot be converted into estradiol by aromatase.<h4>Key Features</h4><ul><li>Targeted identification and quantification of DHT enanthate</li><li>Suitable for oil-based samples and raw API powders</li><li>Analysis by HPLC</li><li>Results for oil samples reported in mg/mL</li><li>Results for raw API powders reported as percentage content</li><li>Optional mass-by-mass purity reporting for raw API powders</li><li>Minimum sample amount of 0.5–1 mL for oil samples</li><li>Minimum sample amount of 200 mg for raw API powders</li><li>Average turnaround time of 7 business days</li></ul><h4>Analysis Parameters</h4><ul><li>Target compound: DHT enanthate</li><li>Testing method: HPLC</li><li>Detection limit cutoff: 15 mg/mL</li><li>Result format for oil samples: mg/mL</li><li>Minimum sample amount for oil samples: 0.5–1 mL</li><li>Result format for raw API powders: % [98%+, 96%+ or % value such as 94.15%]</li><li>Minimum sample amount for raw API powders: 200 mg</li><li>Average turnaround time: 7 business days</li></ul><blockquote>Important Notice: This analysis is intended specifically for DHT enanthate. It is not designed for the analysis of non-esterified DHT.</blockquote><h4>Optional Additional Analyses</h4>The following optional laboratory services are available:<ul><li>Benzyl Alcohol and Benzyl Benzoate Testing</li><li>Complete Raw Analytical Data</li><li>Alternative Result Format: Mass-by-Mass Purity - only for raw API powders</li><li>pH Measurement</li><li>GC–MS Contamination Screening</li><li>Sterility Testing (TAMC and TYMC)</li><li>Heavy Metals Analysis (As, Cd, Pb, Hg)</li><li>Additional Laboratory Report</li></ul>

Epistane analysis

Targeted HPLC analysis of epistane in tablets, capsules, and raw API powders. The test confirms compound identity and determines its content in mg per unit or as a percentage.

The Epistane Analysis is a targeted laboratory test designed to confirm the identity and determine the amount of epistane in oral dosage forms and raw active pharmaceutical ingredient (API) powders.&nbsp;The analysis is suitable for tablets and capsules, with results reported in milligrams per individual dosage unit. Raw API powders can be evaluated by percentage content, with optional purity reporting in % (m/m).<h4>About Epistane</h4>Epistane, also known as methylepitiostanol or 2,3-thioepoxy madol, is a synthetic, orally active anabolic-androgenic steroid structurally related to dihydrotestosterone (DHT). It is a 17α-methylated derivative of epitiostanol and interacts with androgen receptors, producing anabolic and androgenic effects.Epistane has been identified in products marketed as dietary or performance-enhancing supplements. Scientific studies have also associated its use with a risk of liver injury, including cholestasis.<h4>Key Features</h4><ul><li>Targeted identification and quantification of epistane</li><li>Suitable for tablets, capsules, and raw API powders</li><li>Analysis by HPLC</li><li>Results for oral products reported in mg per tablet or capsule</li><li>Results for raw API powders reported as percentage content</li><li>Optional purity reporting in % (m/m) for raw API powders</li><li>Minimum sample amount of three tablets or capsules</li><li>Minimum sample amount of 200 mg for raw API powders</li><li>Average turnaround time of 7 business days</li></ul><h4>Analysis Parameters</h4><ul><li>Target compound: Epistane</li><li>Other names: Hemapolin, 2,3-thioepoxy madol</li><li>CAS number: 4267-80-5</li><li>Testing method: HPLC</li><li>Minimum amount of target compound for evaluation in oral products: 4 mg per tablet / capsule</li><li>Minimum content of target compound for evaluation in raw API powders: 10%</li><li>Result format for oral products: mg per tablet or capsule</li><li>Result format for raw API powders: % [98%+, 96%+ or % value such as 94.15%]</li><li>Minimum sample amount for oral products: 3 tablets / capsules</li><li>Minimum sample amount for raw API powders: 200 mg</li><li>Average turnaround time: 7 business days</li></ul><h4>Optional Additional Analyses</h4>The following optional laboratory services are available:<ul><li>Complete Raw Analytical Data</li><li>Alternative Result Format: Purity in % (m/m) - only for raw API powders</li><li>Batch Variance Testing</li><li>Fentanyl Screening</li><li>GC–MS Contamination Screening</li><li>Heavy Metals Analysis (As, Cd, Pb, Hg)</li><li>Additional Laboratory Report</li></ul>

Human Growth Hormone amount, purity and dimer and higher molecular weight proteins analysis

Laboratory analysis of HGH 191 AA determines identity, amount, purity, dimer content and higher molecular weight proteins in lyophilizates, liquids and raw API powders.

This analysis is designed to identify Human Growth Hormone 191 AA and determine its amount and purity. The test also includes separate measurement of HGH dimer and higher molecular weight proteins, which are important quality parameters for growth hormone products.<h4>Human Growth Hormone 191 AA</h4>Human Growth Hormone, also known as HGH, somatropin or recombinant human growth hormone (rHGH), is a peptide hormone composed of 191 amino acids. It is naturally involved in the regulation of growth, metabolism and other physiological processes.Somatropin used in pharmaceutical products is a recombinant form corresponding to the naturally occurring 191-amino-acid human growth hormone. Product quality depends not only on HGH content and purity but also on the presence of dimers and other higher molecular weight protein forms.An HGH dimer is formed when two growth hormone molecules associate with each other. Because the dimer is still composed of HGH molecules, it may not be classified as a conventional impurity by a standard purity test. A separate analysis is therefore required for its accurate measurement. Increased levels of dimers and other high-molecular-weight protein forms may affect product quality, activity and tolerability.<h4>What the Analysis Determines</h4><ul><li>Identity of HGH 191 AA</li><li>Amount of HGH in the sample</li><li>Growth hormone purity</li><li>Dimer content</li><li>Higher molecular weight protein content</li><li>Results in a format appropriate for the submitted sample type</li></ul><h4>Analysis Parameters</h4><ul><li>Target compound: Human Growth Hormone 191 AA</li><li>Other names: somatropin, HGH, rHGH, 191 AA</li><li>Molecular weight: 22,124 Da</li><li>Testing method: HPLC</li><li>HGH detection limit: 0.2 mg/ml or 0.5 mg/vial</li><li>Dimer and higher molecular weight protein detection limit: 0.008%</li><li>Result format for lyophilizates: mg/vial, IU, purity percentage and dimer percentage</li><li>Result format for liquids: mg/ml, IU, purity percentage and dimer percentage</li><li>Alternative result format: m/m purity, GH purity and dimer percentage</li><li>Minimum lyophilizate sample: one whole unopened vial containing the lyophilizate</li><li>Minimum liquid sample: 1 ml</li><li>Minimum raw API powder sample: 30 mg in a sealed glass vial to prevent moisture absorption</li><li>Average turnaround time: 7 business days</li></ul><h4>Important Notice</h4>Only the 191-amino-acid form of HGH is recognized as Human Growth Hormone by this analytical method. HGH 192 AA is not a target of the test and its presence would result in “HGH not detected” being stated in the report.The alternative m/m purity result format is intended exclusively for raw API powders. Lyophilized products are normally reported in mg/vial, while liquid samples are reported in mg/ml.<h4>Additional Analyses</h4><h5>TFA Analysis</h5><ul><li>Detection and measurement of trifluoroacetic acid (TFA) in the sample. Results are reported in mg per vial.</li></ul><h5>Raw Data</h5><ul><li>Delivery of the available raw analytical data from the primary test and all applicable additional analyses.</li></ul><h5>Fentanyl Presence Analysis</h5><ul><li>Screening of the sample for the presence of fentanyl.</li></ul><h5>Alternative Result Format – m/m Purity</h5><ul><li>Alternative reporting of the result as mass-by-mass purity. This option is intended exclusively for raw API powders.</li></ul><h5>Variance Testing with Dimer Analysis</h5><ul><li>Analysis of multiple vials from the same batch to evaluate variation in HGH content, purity and dimer levels. Dimer content is measured in every submitted vial.</li></ul><h5>Variance Testing</h5><ul><li>Analysis of multiple sample units from the same product batch to assess variation between individual vials or units. Dimer is not measured in the additional samples under this option.</li></ul><h5>pH Measurement</h5><ul><li>Measurement of the sample’s pH value.</li></ul><h5>Endotoxin Analysis</h5><ul><li>Measurement of bacterial endotoxins, particularly lipopolysaccharides (LPS), in the sample. This analysis is available only for finished products and should not be ordered for raw powders.</li><li>The standard test provides accurate results up to 10 EU/vial. Values above 10 EU/vial are estimated and require an additional test with a different dilution for precise determination. Sending two vials is therefore recommended. Where endotoxin levels above 10 EU/vial are expected, the method can be calibrated for the higher range in advance.</li></ul><h5>CHNS Mass Report</h5><ul><li>Elemental analysis providing accurate measurement of nitrogen and sulphur content. The results can be used to determine Net Peptide Content (NPC).</li></ul><h5>Additional Report</h5><ul><li>A separate additional laboratory report issued under a different client name.</li></ul><h5>LC-MS Screening for Peptide Contamination</h5><ul><li>LC-MS screening for contamination with other peptides or peptide degradation products. Detection is limited to peptides included in the laboratory’s available testing database.</li><li>The initial screening provides identification only. If contamination is detected, quantitative measurement may subsequently be ordered.</li></ul><h5>Sterility Testing</h5><ul><li>TAMC and TYMC testing checks the product for the presence of bacteria, yeasts and moulds. Additional unopened sample units must be submitted for the analysis. The average turnaround time for sterility testing is 14 days.</li></ul><h5>Heavy Metals Analysis</h5><ul><li>Detection of selected heavy metals in the sample.</li></ul>

rHGH fragment or AOD-9604 (LCMS+CHNS) analysis

Combined LC-MS, CHNS and HPLC analysis of rHGH fragment 176–191 and AOD-9604 for identification, amount, peptide purity and contamination screening.

This analysis is designed to identify and determine the amount and purity of recombinant Human Growth Hormone fragment 176–191 and AOD-9604. It combines LC-MS, CHNS and HPLC to provide information about peptide identity, net peptide content, peptide purity and potential contamination with other peptides or degradation products.The test can detect and measure either target compound. It is therefore not necessary to know in advance whether the sample contains rHGH fragment 176–191 or AOD-9604.<h4>rHGH Fragment 176–191</h4>rHGH fragment 176–191, also known as somatropin 176–191, is a peptide corresponding to amino acids 176 to 191 of Human Growth Hormone. It consists of 16 amino acids and represents the C-terminal region of the HGH molecule.Its molecular weight is approximately 1,799 Da. It differs from AOD-9604 in the first amino acid of its sequence.<h4>AOD-9604</h4>AOD-9604 is a synthetically modified peptide derived from Human Growth Hormone fragment 176–191. Like the rHGH fragment, it contains 16 amino acids, but its sequence begins with tyrosine instead of phenylalanine.This structural difference allows the two peptides to be distinguished by LC-MS. The molecular weight of AOD-9604 is approximately 1,815 Da.<h4>Analytical Methods</h4><h5>LC-MS – Identification and Contamination Screening</h5>LC-MS is used to confirm the identity of the peptide in the sample. It also provides screening for detectable contamination with other peptides and peptide degradation products.<h5>CHNS – Net Peptide Content Determination</h5>CHNS elemental analysis measures the carbon, hydrogen, nitrogen and sulphur content of the sample. The measured values can be used to determine Net Peptide Content.Because the sample is combusted during CHNS analysis, the result is not affected by solubility issues that may complicate chromatographic measurement of peptide amount.<h5>HPLC – Peptide Purity Determination</h5>HPLC is used to determine peptide purity and the relative proportion of the main peptide component compared with chromatographically detectable impurities.<h4>What the Analysis Determines</h4><ul><li>Identity of rHGH fragment 176–191 or AOD-9604</li><li>Amount of peptide in the sample</li><li>Net peptide content determined by CHNS</li><li>Peptide purity determined by HPLC</li><li>Presence of other peptides or degradation products detected by LC-MS</li><li>Differentiation between rHGH fragment 176–191 and AOD-9604</li></ul><h4>Analysis Parameters</h4><ul><li>Target compounds: rHGH fragment – somatropin 176–191 and AOD-9604</li><li>CAS number of AOD-9604: 221231-10-3</li><li>Molecular weight of AOD-9604: 1,815 Da</li><li>AOD-9604 sequence: H-Tyr-Leu-Arg-Ile-Val-Gln-Cys(1)-Arg-Ser-Val-Glu-Gly-Ser-Cys(1)-Gly-Phe-OH</li><li>CAS number of rHGH fragment: 66004-57-7</li><li>Molecular weight of rHGH fragment: 1,799 Da</li><li>rHGH fragment sequence: H-Phe-Leu-Arg-Ile-Val-Gln-Cys(1)-Arg-Ser-Val-Glu-Gly-Ser-Cys(1)-Gly-Phe-OH</li><li>Identification method: LC-MS</li><li>Amount determination method: CHNS</li><li>Peptide purity method: HPLC</li><li>Detection limit: less than one twentieth of the usual dosage per vial</li><li>Result format for lyophilizates: mg per vial and peptide purity</li><li>Alternative result format: m/m purity and peptide purity</li><li>Minimum lyophilizate sample: one whole unopened vial containing the lyophilizate</li><li>Minimum raw API powder sample: 30 mg in a sealed glass vial to prevent moisture absorption</li><li>Average turnaround time: 7 business days</li></ul><blockquote><h5>Important Notice</h5>The alternative m/m purity result format is intended exclusively for raw API powders. For lyophilized samples, the standard result format provides the peptide amount in mg per vial together with peptide purity.</blockquote><h4>Additional Analyses</h4><h5>TFA Analysis</h5><ul><li>Detection and measurement of trifluoroacetic acid (TFA) in the sample. Results are reported in mg per vial.</li></ul><h5>Raw Data</h5><ul><li>Delivery of the available raw analytical data from the primary test and all applicable additional analyses.</li></ul><h5>Fentanyl Presence Analysis</h5><h5>Alternative Result Format – m/m Purity</h5><ul><li>Alternative reporting of the result as mass-by-mass purity. This option is intended exclusively for raw API powders.</li></ul><h5>Variance Testing</h5><ul><li>Analysis of multiple sample units to assess variation within a single batch. All submitted samples must originate from the same batch of the same product.</li></ul><h5>pH Measurement</h5><h5>Endotoxin Analysis</h5><ul><li>Measurement of bacterial endotoxins, particularly lipopolysaccharides (LPS), in the sample. This analysis is available only for finished products and should not be ordered for raw powders.</li><li>The standard test provides accurate results up to 10 EU per vial. Values above 10 EU per vial are estimated and require an additional test with a different dilution for precise determination. Sending two vials is therefore recommended.</li><li>Where endotoxin levels above 10 EU per vial are expected, the method can be calibrated for the higher range in advance.</li></ul><h5>Additional Report</h5><ul><li>A separate additional laboratory report issued under a different client name.</li></ul><h5>Sterility Testing</h5><ul><li>TAMC and TYMC testing checks the product for the presence of bacteria, yeasts and moulds. Additional unopened sample units must be submitted for analysis. The average turnaround time for this test is 14 days.</li></ul><h5>Heavy Metals Analysis</h5><ul><li>Detection of arsenic, cadmium, lead and mercury in the sample. Testing for other metals can be arranged individually.</li></ul>

Ipamorelin analysis

HPLC analysis of ipamorelin for identity confirmation, amount determination and peptide purity in lyophilized samples and raw API powders.

This analysis is designed to confirm the identity and determine the amount and peptide purity of ipamorelin in lyophilized samples and raw API powders. HPLC testing provides information about the actual ipamorelin content of the sample and the proportion of the main peptide component relative to chromatographically detectable impurities.<h4>Ipamorelin</h4>Ipamorelin is a synthetic peptide composed of five amino acid residues and is therefore classified as a pentapeptide. It is also commonly abbreviated as Ipa.Its sequence contains the modified amino acids Aib and D-2Nal and has an amidated C-terminus. The molecular weight of ipamorelin is approximately 712 Da.The analysis confirms whether the sample contains ipamorelin, determines its amount and evaluates peptide purity.<h4>What the Analysis Determines</h4><ul><li>Identity of ipamorelin</li><li>Amount of ipamorelin in the sample</li><li>Peptide purity</li><li>Results in a format appropriate for the submitted sample type</li></ul><h4>Analysis Parameters</h4><ul><li>Target compound: ipamorelin</li><li>Other name: Ipa</li><li>CAS number: 170851-70-4</li><li>Molecular weight: 712 Da</li><li>Sequence: H-Aib-His-D-2Nal-D-Phe-Lys-NH2</li><li>Testing method: HPLC</li><li>Detection limit: less than one twentieth of the usual dosage per vial</li><li>Result format for lyophilizates: mg per vial and peptide purity</li><li>Alternative result format: m/m purity and peptide purity</li><li>Minimum lyophilizate sample: one whole unopened vial containing the lyophilizate</li><li>Minimum raw API powder sample: 30 mg in a sealed glass vial to prevent moisture absorption</li><li>Average turnaround time: 7 business days</li></ul><blockquote><h5>Important Notice</h5>The alternative m/m purity result format is intended exclusively for raw API powders. For lyophilized samples, the standard result format provides the amount of ipamorelin in mg per vial together with peptide purity.</blockquote><h4>Additional Analyses</h4><h5>TFA Analysis</h5><ul><li>Detection and measurement of trifluoroacetic acid (TFA) in the sample. Results are reported in mg per vial.</li></ul><h5>Raw Data</h5><ul><li>Delivery of the available raw analytical data from the primary test and all applicable additional analyses.</li></ul><h5>Fentanyl Presence Analysis</h5><h5>Alternative Result Format – m/m Purity</h5><ul><li>Alternative reporting of the result as mass-by-mass purity. This option is intended exclusively for raw API powders.</li></ul><h5>Variance Testing</h5><ul><li>Analysis of multiple sample units to assess variation within a single batch. All submitted samples must originate from the same batch of the same product.</li></ul><h5>pH Measurement</h5><h5>Endotoxin Analysis</h5><ul><li>Measurement of bacterial endotoxins, particularly lipopolysaccharides (LPS), in the sample. This analysis is available only for finished products and should not be ordered for raw powders.</li><li>The standard test provides accurate results up to 10 EU per vial. Values above 10 EU per vial are estimated and require an additional test with a different dilution for precise determination. Sending two vials is therefore recommended.</li><li>Where endotoxin levels above 10 EU per vial are expected, the method can be calibrated for the higher range in advance.</li></ul><h5>CHNS Mass Report</h5><ul><li>Elemental analysis providing accurate measurement of nitrogen and sulphur content. The results can be used to determine Net Peptide Content (NPC).</li></ul><h5>Additional Report</h5><ul><li>A separate additional laboratory report issued under a different client name.</li></ul><h5>LC-MS Screening for Peptide Contamination</h5><ul><li>LC-MS screening for contamination with other peptides or peptide degradation products. Detection is limited to peptides included in the available testing portfolio.</li><li>The initial screening provides identification only. If contamination is detected, quantitative measurement may subsequently be ordered.</li></ul><h5>Sterility Testing</h5><ul><li>TAMC and TYMC testing checks the product for the presence of bacteria, yeasts and moulds. Additional unopened sample units must be submitted for analysis. The average turnaround time for this test is 14 days.</li></ul><h5>Heavy Metals Analysis</h5><ul><li>Detection of arsenic, cadmium, lead and mercury in the sample. Testing for other metals can be arranged individually.</li></ul>

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