BKC

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

CAS No. 8001-54-5.

Our Benzalkonium Chloride (BAC / BAK / BKC) product consists of Benzyl (dodecyl) dimethyl ammonium chloride (approx. 65%) and Benzyl (tetradecyl) dimethyl ammonium chloride (approx. 35%). Contains approx. 95% active ingredients.

BKC is manufactured in accordance with the cGMP Guideline ICH Q7 for Active Pharmaceutical Ingredients. Multicompendial analyses according to the current European (Ph.Eur.), United States (USP/NF) and Japanese (JP) Pharmacopoeias. Now also analysed according to the Chinese Pharmacopoeia (ChP).

The appearance of the product is clear, or white to yellowish-white solid or viscous liquid and may contain yellowish-white fragments.. The density of Benzalkonium Chloride (BKC) Solution is approx. 0.98 g/ml.

Chain length: 60-70% w/w C12, 30-40% w/w C14 and Max. 5% w/w C16.

Application

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.

You can read much more about uses and the applications here.

All deliveries of Benzalkonium Chloride (BKC) includes the following documentation and services

• Certificate of Suitability (CEP/COS)
• European Drug Master File (ASMF)
• GMP Certificate (enter Certificate number DK API-H 00073316 and choose Denmark in the country field list)
• Certificate of Analysis (current version of pharmacopoeia)
• Datasheet
• Customer audits
• Stability results
• Declarations, statements (TSE/BSE, residual solvents, GMO, allergens, animal testing, etc.)
• Reach
• Change Notification Statement
• Pre-filled Supplier Questionnaire
• Impurity profile
• Description of the manufacturing process
• Process flowchart
• Packaging details
• Quality agreements

Specifications for Benzalkonium Chloride (BKC) , Ph.Eur., USP/NF, JP

Identification: Complies to Ph.Eur., USP/NF, JP and CHP

Appearance/Clarity of solution: Max. as ref. susp. I / Max. as ref. solution Y6

Purity 1: Clear and colourless to light yellow.

Purity 2: Max 1.0% w/w

Acidity or alkalinity: Max. 0.1 ml 0.1M HCl or NaOH

Ratio of alkyl components: C12: 60 – 70%w/w, C14: 30 – 40%w/w, C16: Max. 5%w/w

Benzyl alcohol (A): Max. 0.5% w/w

Benzaldehyde (B): Max. 0.15% w/w

(Chloromethyl)benzene (C): Max. 0.05% w/w

Any other detectable impurity: Max. 0.10% w/w

Amines and amine salts/ Ammonium compounds: Max. 1.0 ml/g

Water: Max 10.0% w/w

Sulphated ash/Residue on ignition: Max. 0.1% w/w

Water-insoluble matter: No turbidity and insoluble matter

Assay (anhydrous basis): Ph.Eur.: 95.0 – 104.0% w/w USP/NF: 97.0 – 103.0% w/w JP and CHP: 95.0 – 105.0% w/w

Total Aerobic Microbial Count: Max. 1 CFU/g

Total comb. Yeast/Mould Count: Max. 1 CFU/g

Staphylococcus aureus: Absent in 1 g

Pseudomonas aeruginosa: Absent in 1 g

Salmonella spp.: Absent in 10 g

Escherichia coli: Absent in 1 g

Bile-tol. gram-neg. bact.: Absent in 1 g

B. cepacia complex (Bcc): Absent in 1 g

Technical information

Standards: The quality system meets DS/EN ISO 9001. The environmental system meets DS/EN ISO 45001.

Grade: Pharmaceutical grade.

Quality: The product is manufactured in accordance with the cGMP Guide for Active Pharmaceutical Ingredients (API) ICH Q7.

Documentation: Certificate of Suitability (CEP), Drug Master File (DMF)

TSE: Does not contain materials of animal origin.

Solubility: Miscible with water or lower alcohols, such as methanol, ethanol and propanol in all ratios. Not miscible with benzene nor ether.

Compatibility: Mixing with ordinary soaps and/or with anionic detergents may decrease the activity.

Density: Approx. 0.98 g/ml.

Packaging: 1 kg rectangular HDPE plastic containers with tamper proof LDPE Caps or 5 kg round PP plastic containers with tamper proof PP lids.

Shelf life: 5 years.

Storage: Store at temperatures above 15°C. Store protected from excessive heat. May be a liquid, paste or solid depending on the storage conditions.

You can find more information about our Benzalkonium Chloride (BAC / BAK / BKC) products here. Please contact us for information about price and delivery.