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:

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

SETTING A NEW STANDARD

For Peptide API Manufacturing and Services

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