Benzalkonium Chloride 95% with Standard Chain Length (cGMP)

Benzalkonium Chloride Solution 50% (85/15) JP (BKC/BAC/BAK) (CAS No. 8001-54-5.) is a custom-designed product consisting of benzyl (dodecyl) dimethyl ammonium chloride (approximately 85%) and benzyl (tetradecyl) dimethyl ammonium chloride (approximately 15%). It also contains around 50% active ingredients.

Manufactured in accordance with the current good manufacturing practice (cGMP) guideline International Conference on Harmonisation (ICH) Q7 for active pharmaceutical ingredients (API), this alkyl chain length distribution is not covered
by the existing leading pharmacopoeias. The analysis is based on the United States Pharmacopoeia (USP) / National Formulary (NF) pharmacopoeia.

It is available in 1kg bottles (item number: 8100310U) and includes the following documentation and services:

• Good manufacturing practice (GMP) certificate
• Certificate of Analysis
• Datasheet
• Customer audits of FeF Chemicals’ plant
• Stability results
• Declarations and statements such as 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
• Standard operating procedures (SOP)
• Impurity profile
• Description of the manufacturing process
• Process flowchart
• Packaging details
• Material safety data sheet (MSDS)
• International Standards Organisation (ISO) 9001 Certificate

Benzalkonium Chloride Ph.Eur., USP/NF, JP (BKC/BAC/BAK)

Benzalkonium Chloride Ph.Eur., USP/NF, JP (BKC/BAC/BAK) (CAS No. 8001-54-5.) consists of benzyl (dodecyl) dimethyl ammonium chloride (approximately 65%) and benzyl (tetradecyl) dimethyl ammonium chloride (approximately 35%). It also contains around 95% active ingredients.

Manufactured in accordance with the cGMP guideline ICH Q7 for API, its multi-compendial analyses meet the requirements of the current European Pharmacopoeia (Ph.Eur), USP / NF and Japanese Pharmacopoeia (JP).

It is available in 1kg bottle (item number: 8120951) and 5kg pail (item number: 8120955) packaging sizes, and includes the following documentation and services:

• Certificate of Suitability (COS) and Certification of suitability of European Pharmacopoeia monographs (CEP)
• European drug master file (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

Benzalkonium Chloride Ph.Eur., USP/NF (BKC/BAC/BAK)

Benzalkonium Chloride Ph.Eur., USP/NF (BKC/BAC/BAK) (CAS No. 8001-54-5.) consists of benzyl (dodecyl) dimethyl ammonium chloride (approximately 65%) and benzyl (tetradecyl) dimethyl ammonium chloride (approximately 35%). It also contains around 95% active ingredients.

Manufactured in accordance with the cGMP guideline ICH Q7 for API, it is analysed according to the current Ph.Eur and USP/NF.

It is available in 1kg bottle (item number: 8160001U) and 5kg pail (item number: 8160007U) packaging sizes, and includes the following documentation and services:

• CEP / COS
• ASMF
• GMP Certificate
• Certificate of Analysis (current version of pharmacopoeia)
• Datasheet
• Customer audits of FeF Chemicals’ plant
• Stability and stress test results
• Declarations, 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

Benzalkonium Chloride Ph.Eur. (BKC/BAC/BAK)

Benzalkonium Chloride Ph.Eur. (BKC/BAC/BAK) (CAS No. 8001-54-5.) consists of benzyl (dodecyl) dimethyl ammonium chloride (approximately 65%) and benzyl (tetradecyl) dimethyl ammonium chloride (approximately 35%). It also contains around 95% active ingredients.

Manufactured in accordance with the cGMP guideline ICH Q7 for API, it is analysed according to the current Ph.Eur.

It is available in 1kg bottle (item number: 8260001P) and 5kg pail (item number: 8260007P) packaging sizes, and includes the following documentation and services:

• CEP/COS
• 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

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