PEPTIDE QUALITY

CGMP Specifications

Our CGMP specifications and testing procedures include the following:

• Appearance: Solid, off-white to white
• Solubility: Clear solution at specified concentration
• Purity (HPLC/UPLC): 95–98% (phase-dependent)
• Molecular Weight (MS) / AAA: Within ±10% of theoretical value
• Peptide Content: ≥70%
• Counter-Ion Content: Report
• Elemental Impurities (ICP-MS): Report Sb, As, Bi, Cd, Cu, Pb, Hg, Mo, Ag, Sn
• Endotoxin: Report LAL (Gel Clot) per USP
• Bioburden: Report aerobic and spore counts per USP
• Residual TFA: ≤0.1%
• Residual Solvents: GC-MS, report
• Moisture (Karl Fischer): ≤10%