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Analytical development and validation are part of the GMP process to support and justify the specifications for releasing the API. We make a point of performing analytical development early in any project to ensure that no undetected impurities emerge during analytical
validation.

  • Our standard GMP specifications include
  • Appearance
  • Solubility
  • Identity (via mass spectral analysis, amino acid analysis and HPLC)
  • Peptide purity (HPLC)
  • Related substances (HPLC)
  • Assay (peptide content)
  • Counterion content
  • Moisture content
  • Mass balance
  • Trifluoroacetic acid
  • Residual organic solvents
  • Bioburden
  • Endotoxin
  • Other API-specific parameters
PolyPeptide Laboratories A/S
Herredsvejen 2
3400 Hillerød, Denmark

Tel: +45 48207000
Fax: +45 48207005
Email: ppl@polypeptide.com
 

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PolyPeptide Laboratories France SAS
7 rue de Boulogne
67100 Strasbourg, France

Tel +33 388.79.08.79
Fax +33 388.79.18.56
Email: ppl@polypeptide.fr

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PolyPeptide Laboratories San Diego
9395 Cabot Drive
San Diego, CA 92126 USA

Tel +1 858.408.0808
Toll Free +1 800.338.4965
Fax +1 858.408.0799
or +1 800.654.5592
Email: polypeptide@ppl-sd.com

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PolyPeptide Laboratories, Inc.
365 Maple Avenue
Torrance, CA 90503 USA

Tel: +1 310.782.3569
Toll Free: 800.770.0557
Fax: +1 310.782.3645
Email: polypeptide@pplusa.com

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