Every vial has a paper trail.

HPLC — Purity assay

Method: Reverse-phase C18 column with UV detection at 220 nm.

High-Performance Liquid Chromatography separates the target peptide from impurities based on hydrophobicity. Each lot's chromatogram is retained and referenced against a purity acceptance threshold of 98% minimum, with 99%+ typical.

LC-MS/MS — Identity confirmation

Method: Electrospray ionization (ESI+) coupled with Q-TOF mass analyzer.

Liquid Chromatography Tandem Mass Spectrometry confirms that the compound in the vial is exactly the peptide it claims to be. The observed mass is compared to the theoretical mass computed from the amino acid sequence — any mismatch flags the lot for re-testing.

LAL — Endotoxin testing

Method: Kinetic turbidimetric LAL (Limulus Amebocyte Lysate).

Bacterial endotoxin content is measured against a compendial standard curve. Acceptance criterion: below 1 EU/mg for all research-grade peptides.

Quality standards

• Purity: ≥98% (typically 99%+)
• Identity: mass accuracy within compendial tolerances
• Endotoxin: <1 EU/mg
• Documentation: batch-specific COA retained for 7 years
• Facility standards: ISO-17025-aligned