Seven checks. One traceable answer.
A fixed, finished-vial panel — no tiers, no add-ons. Every sample receives all seven checks. Every result identifies the sample, method, specification source, quality status, and technical reviewer.
Homogeneity Profiling
RP-HPLC 214nm (USP <621>)RP-HPLC at 214nm isolates the main peak from related substances at the peptide-bond absorbance wavelength.
Molecular Mass Fingerprinting
LC-MS/MS (ESI+)LC-MS/MS confirms exact monoisotopic mass and fragmentation identity, ±1 Da. Identity consistent with expected mass.
Net Peptide Mass Quantitation
Quantitative HPLC vs reference stdQuantitative HPLC against a qualified reference standard — stripping moisture, salts, and counter-ions like TFA. Report as mg per vial.
Bacterial Endotoxin
Kinetic chromogenic LALKinetic chromogenic LAL (USP <85>). Reported in EU/mL and EU/mg against a stated limit.
Elemental Catalytic Sweep
ICP-MS (USP <232>/<233>)ICP-MS (USP <232>/<233>) for Pb, As, Cd, Hg at sub-ppb. Each element: result, unit, LOQ, specification source.
Microbial Quality
Rapid molecular microarray screenRapid molecular microarray screen. NOT a USP <71> sterility test. Reported as CFU against a limit.
Post-Reconstitution Stability
Forced-degradation stability≥3 independent vials: individual results, mean, SD, CV. Post-reconstitution pH, clarity, and 24h degradation.