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:

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

SETTING A NEW STANDARD

For Peptide API Manufacturing and Services

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