Enhanced TDS
Identification & Functionality
- Chemical Family
- Chemical Name
- Industry
- Pharma & Nutraceuticals Functions
- Technologies
- Product Families
Features & Benefits
- Benefit Claims (Health)
- Labeling Claims
- Quality Standards
Our quality system meets DS/EN ISO 9001 and the ICH Guide Q7 for Active Pharmaceutical Ingredients (ICH Q7). We offer complete QA, QC and RA documentation and compliance with international pharmacopoeias: PhEur, USP/NF, JP and ChP
- Note
Very stable, proven under ICH Q1 conditions
Applications & Uses
- Markets
- Applications
- Application Details
FeF Benzalkonium Chloride (BKC) Ph.Eur., USP/NF, JP is a viscous liquid of quaternary ammonium compounds. FeF BKC Ph.Eur., USP/NF, JP is a very efficient germicide which is active against most common micro-organisms, such as bacteria, fungi, algae and enveloped viruses. FeF BKC Ph.Eur., USP/NF, JP is widely used in pharmaceuticals as the active ingredient (API) due to its anti-microbial effect and as an Excipient because of its preserving properties.
Properties
- Physical Form
- Appearance
- Clear, colourless or slightly yellow, viscous liquid or thick gel paste, Clear, or white to yellowish-white solid or viscous liquid. May contain yellowish-white fragments.
- Miscible in
- Water, Ethanol, Methanol, Propanol
- Immiscible In
- Benzene, Ether
- Compatible with
- Cationic detergents, Non-ionic detergents
- Typical Properties
Value Units Test Method / Conditions Density approx. 0.98 g/ml - - Microbiological Values
Value Units Test Method / Conditions Total Aerobic Microbial Count max. 1 cfu/g - Yeast and Mold Count max. 1 cfu/g - Staphylococcus aureus Absent /1g - Pseudomonas aeruginosa Absent /1g - Salmonella spp. Absent /10g - Escherichia coli Absent /1g - Bile-Tolerant Gram-Negative Bacteria Absent /1g - B. cepacia Complex Absent /1g - - Specifications
Value Units Test Method / Conditions Purity max. 1.0 %w/w - Alkalinity (NaOH) max. 0.1 ml - Alkyl Components Ratio (C12) 60 - 70 %w/w - Alkyl Components Ratio (C14) 30 - 40 %w/w - Alkyl Components Ratio (C16) max. 5 %w/w - Benzyl Alcohol Content max. 0.5 %w/w - Benzaldehyde Content max. 0.15 %w/w - (Chloromethyl)benzene max. 0.05 %w/w - Other Detectable Impurity Content max. 0.10 %w/w - Amine Salt Content max. 1.0 ml/g - Water Content max. 10.0 %w/w - Sulphated Ash Content max. 0.1 %w/w - Assay Content (Anhydrous Basis) 95.0 - 104.0 %w/w - Assay Content (Anhydrous Basis) 95.0 - 105.0 %w/w - Assay Content (Anhydrous Basis) 97.0 - 103.0 %w/w - - Solubility Data
Value Units Test Method / Conditions Water - Insoluble Matter No turbidity and insoluble matter - - - Solubility Data
Soluble in : Miscible with water or lower alcohols, such as methanol, ethanol and propanol in all ratios. Not miscible with benzene nor ether.
Regulatory & Compliance
- Certifications & Compliance
- Quality Standards
Technical Details & Test Data
- Product Information
- Composition: FeF BKC Ph.Eur., USP/NF, JP consists of Benzyl (dodecyl) dimethyl ammonium chloride (approx. 65%) and Benzyl (tetradecyl) dimethyl ammonium chloride (approx. 35%). FeF BKC Ph.Eur., USP/NF, JP contains approx. 95% active ingredients.
- Chain length: 60-70% w/w C12, 30-40% w/w C14 and Max. 5% w/w C16.
- Grade: Pharmaceutical grade.
- Quality: The product is manufactured in accordance with the cGMP Guide for Active Pharmaceutical Ingredients (API) ICH Q7.
Packaging & Availability
- Country Availability
- Packaging Information
1 kg is packaged in cylindric HDPE plastic containers with tamper proof HDPE screw lids. 5 kg is packaged in round HDPE plastic containers with screw lids and tamper proof strips.
Storage & Handling
- Shelf Life
- 5 years
- Storage Conditions
Store at temperatures above 15°C. Store protected from excessive heat. May be a liquid, paste or solid depending on the storage conditions.