BKC 50%

FeF Benzalkonium Chloride (BKC) Solution 50% (53/30/15/2) Ph.Eur., USP/NF

CAS No. 8001-54-5.

This product is custom-designed consisting of Benzyl (dodecyl) dimethyl ammonium chloride (approx. 53%), Benzyl (tetradecyl) dimethyl ammonium chloride (approx. 30%), Benzyl (hexadecyl) dimethyl ammonium chloride (approx. 15%) and Benzyl (octadecyl) dimethyl ammonium chloride (approx. 2%). It contains approx. 50% active ingredients.

BKC 50% (53/30/15/2) is manufactured in accordance with the cGMP Guideline ICH Q7 for Active Pharmaceutical Ingredients and is analysed according to the current European (Ph.Eur.) and United States (USP/NF) Pharmacopoeias.

The appearance of this product is clear, slightly yellow or colourless, viscous liquid. The density of Benzalkonium Chloride Solution 50% (53/30/15/2) is approx. 0.98 g/ml.

Chain length: 50.5-55.5% w/w C12, 27.5-32.5% w/w C14, 15-20% w/w C16, 2-5% w/w C18.

Please note that this product is only manufactured to order.

You can find our other BKC 50% products here:

FeF Benzalkonium Chloride (BKC) Solution 50% Ph.Eur., USP/NF

FeF Benzalkonium Chloride (BKC) Solution 50% Ph.Eur., USP/NF, JP

FeF Benzalkonium Chloride (BCK) Solution 50% (45/55) Ph.Eur., USP/NF

Application

FeF Benzalkonium Chloride Solution (BKC) 50% (53/30/15/2) Ph.Eur., USP/NF is a viscous, aqueous solution of quaternary ammonium compounds.

FeF BKC 50% (53/30/15/2) Ph.Eur., USP/NF is a very efficient germicide, active against most common micro-organisms, such as bacteria, algae, fungi, and enveloped viruses. FeF BKC 50% (53/30/15/2) Ph.Eur., 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.

If you wish to read more about the uses and applications, click here.

All deliveries of Benzalkonium Chloride (BKC) 50% includes the following documentation and services

• Certificate of Suitability (CEP/COS)
• European Drug Master File (ASMF)
• DUNS and NDC numbers 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 agreements

Specifications

Identification: Complies to Ph.Eur., USP/NF

Appearance/Clarity of solution: Max. as reference suspension I Max. as reference solution Y6

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

Ratio of alkyl components: C12: 50.5 – 55.5% w/w, C14: 27.5 – 32.5% w/w, C16: 15 – 20% w/w, C18: 2 – 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: Max. 0.5 ml/g

Sulphated ash: Max. 0.1% w/w

Assay: 47.5 – 52.5% w/v

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: Packaged in rectangular 1kg HDPE containers with tamper proof HDPE caps.

Shelf life: 5 years.

Storage: Store at temperatures above 15°C. Store protected from excessive heat. May form a solid gel or a viscous precipitate at low temperatures.

You can read more about our different Benzalkonium Chloride (BAC / BAK / BKC) products here. In case of questions aboyt price and delivery, please contact us.