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Novo Nordisk Pharmatech A/S

Supplier of Quaternary Ammonium Compounds and Recombinant Insulin Human AF

Benzalkonium Chloride Solution 50% (85/15) JP (BKC/BAC/BAK)

Novo Nordisk Pharmatech A/S

CAS No. 8001-54-5. Custom design product consisting of Benzyl (dodecyl) dimethyl ammonium chloride (approx. 85%) and Benzyl (tetradecyl) dimethyl ammonium chloride (approx. 15%).Contains approx. 50% active ingredients.Manufactured in accordance with the cGMP Guideline ICH Q7 for Active Pharmaceutical Ingredients. Analysed according to the current Japanese (JP) Pharmacopoeia.

Packaging sizes:

1kg bottle – Item number: 8100310U

Documentation and services:

  • 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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