Certificate of Analysis (COA)
A document reporting quality testing results for a specific batch of product, typically including purity (HPLC), identity (mass spectrometry), endotoxin levels, sterility, and other quality metrics. COAs are essential quality documentation for both approved peptide drugs and research compounds.
Technical Context
A peptide drug COA typically includes: product identification (name, batch/lot number, manufacturing date, expiry date), appearance (physical description — white lyophilised powder, clear colourless solution), identity tests (mass spectrometry molecular weight, amino acid composition), purity (HPLC — percentage of target peptide peak area, with individual and total impurity limits), related substances (specified and unspecified impurities below ICH thresholds), water content (Karl Fischer titration — critical for lyophilised products), peptide content (net peptide per vial/unit), endotoxin (LAL test, EU/mg), sterility (14-day incubation test), pH (for solutions), and any product-specific tests. Each result is compared against pre-defined specifications. COAs are batch-specific — each manufacturing batch has its own COA.