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Novo Nordisk Pharmatech|15 February 2018

FeF® CTAB USP/NF

CTAB or Cetrimonium bromide (CAS No. 57-09-0) can be used for several purposes in the pharmaceutical industry.

CTAB or Cetrimonium bromide (CAS No. 57-09-0) can be used for several purposes in the pharmaceutical industry.

As a pharmaceutical ingredient, it is an antiseptic agent with various antibacterial, antifungal and other antimicrobial properties. It is used in various products such as throat lozenges and antiseptic topical gels and creams for a range of purposes. As a processing aid or auxiliary, it can be used in the downstream vaccine manufacturing process, typically for polysaccharide vaccines.

Packaging sizes:

  • Item number: 7800022, 25kg (double plastic bags in a cardboard box)
  • Item number: 7800023, 25kg (double plastic bags in plastic drums)

Uniform quality

Novo Nordisk Pharmatech’s FeF® CTAB USP/NF product has proven efficacy against a broad spectrum of microorganisms, including gram-positive and gram-negative bacteria, as well as acid-fast bacteria, yeast and mould.

The product is effective through a wide pH ranges, are surface active / adhesive cationic agents and do not add unpleasant odours or colours to finished formulations.

The uniform quality of the company’s products is ensured by its efficient quality management systems (QMS), dedicated equipment, well-established processes and rigorous laboratory quality control.

FeF® CTAB USP/NF consists of Hexadecyl trimethyl ammonium bromide and contains approximately 99% active ingredients. Product Item number 7800023 is only manufactured to order.

Documentation and services

Novo Nordisk provides a range of documentation, including:

  • European drug master file (ASMF)
  • Good manufacturing practice (GMP) certificate
  • Certificate of Analysis (current version of Pharmacopoeia)
  • Datasheet
  • Customer audits
  • Stability results
  • Declarations and statements such as transmissible spongiform encephalopathy (TSE) / bovine spongiform encephalopathy (BSE) statements, residual solvents, genetically modified organism (GMO), allergens and animal testing
  • Reach
  • Change notification statement
  • Pre-filled supplier questionnaire
  • Impurity profile
  • Description of the manufacturing process
  • Process flowchart
  • Packaging details
  • Quality agreements

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