Quality & Compliance

FDA-Inspected Peptide Manufacturing

AmbioPharm operates an FDA-inspected U.S. based manufacturing site in North Augusta, SC. The facility is capable of producing peptide API’s from gram to multi-kilogram quantities.

The U.S. Food & Drug Administration (FDA) performs Pre-Approval Inspections (PAIs) and regular inspections of facilities under the Federal Food, Drug, and Cosmetic (FD&C) Act. AmbioPharm complies with all FDA inspections and PAIs while demonstrating a consistent commitment to the highest levels of quality and compliance.

View the FDA Drug Establishments Current Registration Site
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Rigid Quality Control

• Analytical Testing
• Purity: (Ultra) High Pressure Liquid Chromatography (UPLC/HPLC)
• Residual Solvents: Gas Chromatography (GC)
• Molecular Weight: ESI- Mass Spectroscopy
• Related-Substances: Liquid Chromatography-Mass Spectrometry (LC-MS)
• Counter Ion Content: Ion Chromatography (IC)
• Size Exclusion Chromatography (SEC)
• Water Content: Karl Fischer (KF)
• Peptide Content: Nitrogen Content
• Amino Acid Composition: Amino Acid Analysis (AAA)
• Bioburden
• Endotoxin