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Novo Nordisk Pharmatech A/S

Supplier of Quaternary Ammonium Compounds and Recombinant Insulin Human AF

Myristalkonium Chloride ( cGMP)

Novo Nordisk Pharmatech A/S

Also known as benzalkonium chloride powder and myristyl dimethyl ammonium chloride, myristalkonium chloride (MKC) pharma (CAS No. 139-08-2) consists of benzyl (tetradecyl) dimethyl ammonium chloride. It also contains approximately 99% active ingredients.

Manufactured in accordance with the current good manufacturing practices (cGMP) guideline International Conference on Harmonisation (ICH) Q7 for active pharmaceutical ingredients (API), this product is not covered by the existing leading pharmacopoeias. The analysis is based on the European Pharmacopoeia (Ph.Eur) for benzalkonium chloride.

It is available in a 25kg carton (item number: 8060020) packaging size, and includes the following documentation and services:

  • European Drug Master File (ASMF)
  • Good manufacturing practice (GMP) certificate
  • Certificate of Analysis
  • Datasheet
  • Customer audits of FeF Chemicals’ plant
  • Stability and stress test results
  • Declarations and statements such as transmissible spongiform encephalopathies (TSE) / bovine spongiform encephalopathy (BSE), residual solvents, genetically modified organisms (GMO), allergens, environment and animal testing
  • Change notification statement
  • Answering questionnaires
  • Methods of analysis (FeF SOP)
  • Impurity profile
  • Description of the manufacturing process
  • Process flowchart
  • Packaging details
  • Material safety data sheet (MSDS)
  • International Standards Organisation (ISO) 9001 Certificate

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