Product information

FeF Benzalkonium Chloride Ph.Eur., USP/NF, JP

CAS No. 8001-54-5.

Consists of Benzyl (dodecyl) dimethyl ammonium chloride (approx. 65%) and Benzyl (tetradecyl) dimethyl ammonium chloride (approx. 35%). Contains approx. 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. Now also analysed according to the Chinese Pharmacopoeia (ChP).

Documentation and services

• Certificate of Suitability (CEP/COS)
• European Drug Master File (ASMF)
• GMP Certificate (enter Certificate number DK API-H 00073316 and choose Denmark in the country field list)
• Certificate of Analysis (current version of pharmacopoeia)
• Datasheet
• Customer audits
• Stability results
• Declarations, statements (TSE/BSE, residual solvents, GMO, allergens, animal testing, etc.)
• Reach
• Change Notification Statement
• Pre-filled Supplier Questionnaire
• Impurity profile
• Description of the manufacturing process
• Process flowchart
• Packaging details
• Quality agreements