Strong Cetrimide Solution 40% BP Pharma with Ethanol

Also known as Cetrimide, Cetrimoni bromidum and Tetradecyl trimethyl ammonium bromide (TTAB), Strong Cetrimide Solution 40% BP Pharma with ethanol (CAS No. 1119-97-7.) consists of dodecyl trimethyl ammonium bromide (approximately 20%), trimethyl tetradecyl ammonium bromide (approximately 70%) and hexadecyl trimethyl ammonium bromide (approximately 10%). It also contains around 7.5% volume/volume (v/v) ethanol.

Manufactured in accordance with the current good manufacturing practice (cGMP) guideline International Conference on Harmonisation (ICH) Q7 for active pharmaceutical ingredients (API), the product is analysed according to the current British Pharmacopoeia (BP).

Strong Cetrimide Solution 40% BP Pharma with ethanol is available in a 200kg drum packaging size, item number 8570200S.

Documentation and services

Novo Nordisk Pharmatech offers a wide range of documentation and services for strong Cetrimide Solution 40% BP Pharma with ethanol, including

• European drug master file (ASMF)
• Good manufacturing practice (GMP) certificate
• Certificate of Analysis (the current version of Pharmacopoeia)
• Datasheets
• Customer audits of FeF Chemicals’ plant
• Stability and stress test results
• Declarations and statements for aspects such as transmissible spongiform encephalopathies (TSE) / bovine spongiform encephalopathy (BSE), residual solvents, genetically modified organisms (GMO), allergens, environment and animal testing)
• Change notification statements
• Answering of questionnaires
• Standard operating procedures (SOP)
• Impurity profiles
• Descriptions of manufacturing processes
• Process flowcharts
• Packaging details
• Material safety data sheets (MSDS)
• International Standards Organisation (ISO) 9001 certificate

Strong cetrimide solution 40% BP pharma with isopropyl alcohol

Also known as cetrimide, cetrimoni bromidum and tetradecyl trimethyl ammonium bromide (TTAB), Strong cetrimide solution 40% BP pharma with isopropyl alcohol (CAS No. 1119-97-7.) consists of dodecyl trimethyl ammonium bromide (approximately 20%) and trimethyl tetradecyl ammonium bromide approximately 80%). It also contains around 7.5% v/v isopropyl alcohol.

Manufactured in accordance with the cGMP Guideline ICH Q7 for API, it is analysed according to the current BP. It is available in a 200kg drum packaging size, item number: 8570201.

Documentation and services

Novo Nordisk Pharmatech offers a wide range of documentation and services for strong cetrimide solution 40% BP pharma with isopropyl alcohol, including:

• ASMF
• GMP certificate
• Certificate of analysis the (current version of pharmacopoeia)
• Datasheet
• Customer audits of FeF Chemicals’ plant
• Stability and stress test results
• Declarations and statements such as TSE/BSE, residual solvents, GMO, allergens, environment and animal testing
• Change notification statements
• Answering of questionnaires
• SOPs
• Impurity profiles
• Descriptions of manufacturing processes
• Process flowcharts
• Packaging details
• MSDS
• ISO 9001 Certificate

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