BKC 17%

FeF Benzalkonium Chloride (BKC) Solution 17% USP/NF

CAS No. 8001-54-5.

Our custom-designed Benzalkonium Chloride (BAC / BAK / BKC) solution 17% consisting of Benzyl (dodecyl) dimethyl ammonium chloride (approx. 65%) and Benzyl (tetradecyl) dimethyl ammonium chloride (approx. 35%). Contains approx. 17% active ingredients.

Manufactured in accordance with the cGMP Guideline ICH Q7 for Active Pharmaceutical Ingredients. Analysed according to the current United States (USP/NF) Pharmacopoeia.

The appearance of the product is clear, colourless or slightly yellow, viscous liquid. The density of Benzalkonium Chloride (BKC) Solution 17% is approx. 0.99 g/ml.

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

FeF Benzalkonium Chloride Solution (BKC) 17% USP/NF is a viscous, aqueous solution of quaternary ammonium compounds.

FeF BKC 17% USP/NF is a very efficient germicide which is active against most common micro-organisms, such as bacteria, fungi, algae and enveloped viruses. FeF BKC 17% USP/NF 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) 17% includes the following documentation and services

• European Drug Master File (ASMF)
• DUNS for US import
• 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 agreement

Specifications for Benzalkonium Chloride (BKC) Solution 17%, Ph.Eur., USP/NF

Identification: Complies to USP/NF

Amines and amine salts: Max. 0.17 ml/g

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

Benzyl alcohol: Max. 0.5% w/w

Benzaldehyde: Max. 0.15% w/w

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

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

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

Assay: 16.15 – 17.85% w/v

Total Aerobic Microbial Count: Max. 1 CFU/g

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

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. 0.99 g/ml.

Packaging: Packaged in rectangular 25kg HDPE containers with tamper proof HDPE caps.

Shelf life: 5 years.

Storage: Store protected from excessive heat.

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