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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.
- 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)
- 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
- ISO 9001 Certificate
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