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Novo Nordisk Pharmatech A/S

Supplier of Quaternary Ammonium Compounds and Recombinant Insulin Human AF

Cetyl Trimethyl Ammonium Bromide (cGMP)

Novo Nordisk Pharmatech A/S

Also known as cetrimonium bromide and hexadecyl trimethyl ammonium bromide (HTAB), cetyl trimethyl ammonium bromide (CTAB) USP/NF (CAS No. 57-09-0.) consists of trimethyl hexadecyl ammonium bromide. It also contains approximately 99% active ingredients.

Manufactured in accordance with the current good manufacturing practice (cGMP) guideline International Conference on Harmonisation (ICH) Q7 for active pharmaceutical ingredients (API), it is analysed according to the current United States Pharmacopoeia (USP) and the National Formulary (NF).

It is available in a 25kg carton (item number: 8570028) packaging size, and includes the following documentation and services:

  • European Drug Master File (ASMF)
  • Good manufacturing practice (GMP) certificate
  • Certificate of Analysis (current version of pharmacopoeia)
  • 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
  • MSDS
  • International Standards Organisation (ISO) 9001 Certificate

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