As one of the leading suppliers of peptide APIs worldwide, AmbioPharm provides rigid quality control, SOPs, training, and rigorous testing.
FDA-Inspected Peptide ManufacturingAmbioPharm 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
Rigid Quality ControlAnalytical 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)