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Novo Nordisk Pharmatech|16 April 2014

FeF® Benzalkonium Chloride Ph.Eur., USP/NF, JP (BKC/BAC/BAK)

CAS No. 8001-54-5. Consists of Benzyl (dodecyl) dimethyl ammonium chloride (approx. 65%) and Benzyl (tetradecyl) dimethyl ammonium chloride (approximately 35%). Contains approximately 95% active ingredients.

BKC

CAS No. 8001-54-5. Consists of Benzyl (dodecyl) dimethyl ammonium chloride (approx. 65%) and Benzyl (tetradecyl) dimethyl ammonium chloride (approximately 35%). Contains approximately 95% active ingredients.

Manufactured in accordance with the cGMP Guideline ICH Q7 for Active Pharmaceutical Ingredients.

Multicompendial analyses according to the current European (Ph.Eur.), United States (USP/NF) and Japanese (JP) Pharmacopoeias.

Packaging sizes:

  • Item number: 7800012, 1kg bottle
  • Item number: 7800013, 5kg pail

Documentation and services:

  • Certificate of Suitability (CEP/COS)
  • European Drug Master File (ASMF)
  • GMP Certificate
  • Certificate of Analysis (current version of pharmacopoeia)
  • Datasheet
  • Customer audits of FeF Chemicals’ plant
  • Stability and stress test results
  • Declarations, statements (TSE/BSE, residual solvents, GMO, allergens, environment, animal testing, etc.)
  • Change Notification Statement
  • Answering of questionnaires
  • Methods of analysis (FeF SOP)
  • Impurity profile
  • Description of the manufacturing process
  • Process flowchart
  • Packaging details
  • MSDS
  • ISO 9001 Certificate

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