FeF Benzalkonium Chloride Solution 17% USP/NF
CAS No. 8001-54-5.
Custom-designed solution consisting of Benzyl (dodecyl) dimethyl ammonium chloride (approx. 65%) and Benzyl (tetradecyl) dimethyl ammonium chloride (approx. 35%). Contains approx. 17% active ingredients.
Manufactured in accordance with the cGMP Guideline ICH Q7 for Active Pharmaceutical Ingredients. Analysed according to the current United States (USP/NF) Pharmacopoeia.
Documentation and services
- European Drug Master File (ASMF)
- DUNS for US import
- GMP Certificate (enter Certificate number DK API-H 00073316 and choose Denmark in the country field list)
- Certificate of Analysis (current version of pharmacopoeia)
- Customer audits
- Stability results
- Declarations, statements (TSE/BSE, residual solvents, GMO, allergens, animal testing, etc.)
- Change Notification Statement
- Pre-filled Supplier Questionnaire
- Impurity profile
- Description of the manufacturing process
- Process flowchart
- Packaging details
- Quality agreement