Cetrimide Ph.Eur and Strong Cetrimide (cGMP)

Also known as cetrimoni bromidum, tetradecyl trimethyl ammonium bromide (TTAB), myristyl trimethyl ammonium bromide (MTAB) and mytrimonium bromide, Cetrimide Ph.Eur (CAS No. 1119-97-7.) consists of trimethyl tetradecyl ammonium bromide. It also contains approximately 99% active ingredients.

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

It is available in a 25kg carton (item number: 8070004P) packaging size, and includes the following documentation and services:

• Certificate of Suitability (COS) / Certificate of Suitability to the monographs of the European Pharmacopoeia (CEP)
• Good manufacturing practice (GMP) certificate
• Certificate of Analysis (current version of pharmacopoeia)
• Datasheet
• Customer audits of FeF Chemicals’ plant
• Stability and stress test results
• Declarations, statements transmissible spongiform encephalopathies (TSE) / Bovine Spongiform Encephalopathy (BSE), residual solvents, genetically modified organisms (GMO), allergens, environment and animal testing
• Change notification statement
• Answering of questionnaires
• Methods of analysis (FeF SOP)
• Impurity profile
• Description of the manufacturing process
• Process flowchart
• Packaging details
• Materials safety data sheet (MSDS)
• International Standards Organisation (ISO) 9001 Certificate

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 cGMP guideline ICH Q7 for API, it is analysed according to the current British Pharmacopoeia (BP).

It is available in a 200kg drum (item number: 8570200S) packaging size, and includes the following documentation and services:

• ASMF
• GMP certificate
• Certificate of Analysis (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 statement
• Answering of questionnaires
• Methods of analysis (FeF SOP)
• Impurity profile
• Description of the manufacturing process
• Process flowchart
• Packaging details
• MSDS
• 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 (item number: 8570201) packaging size, and includes the following documentation and services:

• ASMF
• GMP certificate
• Certificate of Analysis (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 statement
• Answering 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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