Benzalkonium Chloride Solution with Standard Chain Length ( cGMP)

Benzalkonium Chloride Solution 50% 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 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), its multi-compendial analyses was made according to the current European Pharmacopoeia (Ph.Eur), United States Pharmacopoeia (USP) / National Formulary (NF) and Japanese Pharmaocpoeia (JP).

It is available in 1kg bottle (item number: 8120501), 5kg bottle (Item number: 8120505) and 25kg jug (item number: 8120525) packaging sizes, and includes the following documentation and services:

• Certificate of Suitability (COS) / Certificate of Suitability to the monographs of the European Pharmacopoeia (CEP)
• European Drug Master File (ASMF)
• 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 organsism (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% Ph.Eur., USP/NF (BKC/BAC/BAK)

Benzalkonium Chloride Solution 50% 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 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: 8100301U), 5kg bottle (item number: 8100305U) and 25kg jug (item number: 8100307U) 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 questionnaires
• Methods of analysis (FeF SOP)
• Impurity profile
• Description of the manufacturing process
• Process flowchart
• Packaging details
• MSDS
• ISO 9001 Certificate

Benzalkonium Chloride Solution 50% Ph.Eur. (BKC/BAC/BAK)

Benzalkonium Chloride Solution 50% 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 50% active ingredients.

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

It is available in 1kg bottle (item number: 8200301P), 5kg bottle (item number: 8200305P) and 25kg jug (item number: 8200307P) 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 questionnaires
• Methods of analysis (FeF SOP)
• Impurity profile
• Description of the manufacturing process
• Process flowchart
• Packaging details
• MSDS
• ISO 9001 Certificate

Benzalkonium Chloride Solution 17% USP/NF (BKC/BAC/BAK)

Benzalkonium Chloride Solution 17% USP/NF (BKC/BAC/BAK) (CAS No. 8001-54-5.) is a custom-designed solution consisting of benzyl (dodecyl) dimethyl ammonium chloride (approximately 65%) and benzyl (tetradecyl) dimethyl ammonium chloride (approximately 35%). It also contains around 17% active ingredients.

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

It is available in a 25kg jug (item number: 8100017U) packaging size, 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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