Quality & Compliance

AmbioPharm maintains the highest level of quality and compliance in its FDA-inspected manufacturing plants in North Augusta, South Carolina, and in Shanghai, China.

As one of the world’s leading suppliers of peptide APIs, we provide rigid quality controls, standard operating procedures (SOPs), training, and rigorous testing.

As a part of our quality systems, over 50 experienced Quality Assurance staff and consultants review our operations on a consistent basis.

The highest standards are employed across all locations:

Corporate SOPs consistent with Q7 Good Manufacturing Practices for Active Pharmaceutical Ingredients as established by the FDA
Site-specific SOPs at each location
Experienced chemists specifically training for manufacturing under cGMP (Current Good Manufacturing Practice standards) as established by the FDA
Experienced QA/QC (Quality Assurance / Quality Control) staff at all locations
QC testing and QA release of all raw materials
Production batch records in English at all sites
Qualified facilities, utilities, and equipment
QA physical control of all documents and drug substance

High-quality QC testing performed at AmbioPharm laboratories:

High Performance Liquid Chromatography (HPLC)
Ultra-Performance Liquid Chromatography (UPLC)
Amino Acid Analysis (AAA)
Karl-Fischer (Water determination)
Gas Chromatography (GC)
Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS)
Ultraviolet Visible Spectrophotometry (UV/Vis)
Fourier Transform Infrared Spectroscopy (FTIR)
Optical Rotation
pH
Peptide Sequencing
Peptide Content Nitrogen Analysis
Melting Point
Endotoxin and Bioburden
Stability Chambers

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