Cagrilintide/Semaglutide (CagriSema) blend analysis

This analysis is designed to confirm the identity and separately determine the amount of cagrilintide and semaglutide in a combined lyophilized sample. HPLC testing measures the content of both target peptides, with results reported in mg per vial.

Peptide purity cannot be reliably determined in a blend because impurities originating from the individual peptides may overlap in the chromatographic data and cannot be clearly attributed to a specific component.

CagriSema

CagriSema refers to a combination of cagrilintide and semaglutide in a single product. Cagrilintide is a synthetic lipidated amylin analogue, while semaglutide is a modified GLP-1 peptide analogue.

Because the sample contains two different peptide components, the analysis focuses on confirming their identity and separately determining the amount of each peptide. The report therefore provides individual results for cagrilintide and semaglutide.

What the Analysis Determines

• Identity of cagrilintide
• Identity of semaglutide
• Amount of cagrilintide in the sample
• Amount of semaglutide in the sample
• Results in mg per vial for each target peptide

Analysis Parameters

• Target compounds: cagrilintide and semaglutide
• Blend name: CagriSema
• Testing method: HPLC
• Detection limit: less than one twentieth of the usual dosage per vial
• Result format: mg per vial for each target peptide
• Minimum sample amount: one whole unopened vial containing the lyophilizate
• Average turnaround time: 7 business days
• Peptide purity: not measured

Important Notice

Peptide purity cannot be determined for a cagrilintide/semaglutide blend. Impurities associated with both peptides may overlap in the chromatographic data and cannot be reliably assigned to the individual target compounds.

The final report provides identification and separately measured amounts of cagrilintide and semaglutide. Peptide purity is not included in the results.

Additional Analyses

Raw Data

• Delivery of the available raw analytical data from the primary test and all applicable additional analyses.

Fentanyl Presence Analysis

Variance Testing

• 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.

pH Measurement

Endotoxin Analysis

• 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.
• 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.
• Where endotoxin levels above 10 EU per vial are expected, the method can be calibrated for the higher range in advance.

Additional Report

• A separate additional laboratory report issued under a different client name.

LC-MS Screening for Peptide Contamination

• LC-MS screening for contamination with other peptides or peptide degradation products. Detection is limited to peptides included in the available testing portfolio.
• The initial screening provides identification only. If contamination is detected, quantitative measurement may subsequently be ordered.

Sterility Testing

• 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.

Heavy Metals Analysis

• Detection of arsenic, cadmium, lead and mercury in the sample. Testing for other metals can be arranged individually.