Crystagen Analysis

This analysis is designed to confirm the identity and determine the amount and peptide purity of Crystagen in lyophilized samples and raw API powders. HPLC testing provides information about the target peptide content and its purity relative to chromatographically detectable impurities.

Crystagen

Crystagen is a short synthetic peptide composed of three amino acid residues and is therefore classified as a tripeptide. Its Glu-Asp-Pro sequence consists of glutamic acid, aspartic acid and proline.

The molecular weight of Crystagen is approximately 359 Da. HPLC analysis confirms the presence of Crystagen in the sample, determines its amount and evaluates peptide purity.

What the Analysis Determines

• Identity of Crystagen
• Amount of Crystagen in the sample
• Peptide purity
• Results in a format appropriate for the submitted sample type

Analysis Parameters

• Target compound: Crystagen
• Molecular weight: 359 Da
• Sequence: Glu-Asp-Pro-OH
• Testing method: HPLC
• Detection limit: less than one twentieth of the usual dosage per vial
• Result format for lyophilizates: mg per vial and peptide purity
• Alternative result format: m/m purity and peptide purity
• Minimum lyophilizate sample: one whole unopened vial containing the lyophilizate
• Minimum raw API powder sample: 30 mg in a sealed glass vial to prevent moisture absorption
• Average turnaround time: 7 business days

Important Notice

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 Crystagen in mg per vial together with peptide purity.

Additional Analyses

TFA Analysis

• Detection and measurement of trifluoroacetic acid (TFA) in the sample. Results are reported in mg per vial.

Raw Data

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

Fentanyl Presence Analysis

Alternative Result Format – m/m Purity

• Alternative reporting of the result as mass-by-mass purity. This option is intended exclusively for raw API powders.

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.

CHNS Mass Report

• Elemental analysis providing accurate measurement of nitrogen and sulphur content. The results can be used to determine Net Peptide Content (NPC).

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.