Quality & Compliance

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

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

More than 40 experienced Quality Assurance staff and consultant review 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
Amino Acid Analysis
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 Meter
Peptide Sequencer
Peptide Content Nitrogen Analysis
Melting Point Apparatus
Endotoxin and Bioburden
Stability Chambers

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