Benzalkonium Chloride with Special Chain Length ( cGMP)

Benzalkonium Chloride Solution 50% (53/30/15/2) Ph.Eur., USP/NF (BKC/BAC/BAK) (CAS No. 8001-54-5.) is a custom-designed product consisting of benzyl (dodecyl) dimethyl ammonium chloride (approximately 53%), benzyl (tetradecyl) dimethyl ammonium chloride (approximately 30%), benzyl (hexadecyl) dimethyl ammonium chloride (approximately 15%) and benzyl (octadecyl) dimethyl ammonium chloride (approximately 2%). It also contains around 50% active ingredients.

Manufactured in accordance with the current good manufacturing practice (cGMP) guideline ICH Q7 for active pharmaceutical ingredients (API), it is analysed according to the current European Pharmacopoeia (Ph.Eur) and United States Pharmacopoeia (USP) /  National Formulary (NF).

It is available in a 1kg bottle (item number: 8100315U) packaging size, and includes the following documentation and services:

• 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 and statements such as transmissible spongiform encephalopathies (TSE) / Bovine Spongiform Encephalopathy (BSE), residual solvents, genetically modified organism (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
• Material safety data sheet (MSDS)
• International Standards Organisation (ISO) 9001 Certificate

Benzalkonium Chloride Solution 50% (45/55) Ph.Eur., USP/NF (BKC/BAC/BAK)

Benzalkonium Chloride Solution 50% (45/55) Ph.Eur., USP/NF (BKC/BAC/BAK) (CAS No. 8001-54-5.) is a custom-designed product consisting of benzyl (dodecyl) dimethyl ammonium chloride (approximately 45%) and benzyl (tetradecyl) dimethyl ammonium chloride (approximately 55%). It also contains around 50% 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: 8302311U) and 25kg jug (item number: 8302307U) packaging sizes, and includes the following documentation and services:

• CEP / COS
• 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

It is available in 1kg bottle (item number: 8100310U) packaging sizes, and includes the following documentation and services:

• 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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