BKC 50%

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

CAS No. 8001-54-5.

The custom-designed Benzalkonium Chloride (BAC / BAK / BKC) 50% product consisting of Benzyl (dodecyl) dimethyl ammonium chloride (approx. 45%) and Benzyl (tetradecyl) dimethyl ammonium chloride (approx. 55%). Contains approx. 50% active ingredients.

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

The appearance of the product is clear, colourless or slightly yellow, viscous liquid. The density of Benzalkonium Chloride (BKC) Solution 50% is approx. 0.98 g/ml.

Chain length: 42.5-47.5% w/w C12 and 52.5-57.5% w/w C14.

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

Application

FeF Benzalkonium Chloride Solution (BKC) 50% (45/55) Ph.Eur., USP/NF is a viscous, aqueous solution of quaternary ammonium compounds.

FeF BKC 50% (45/55) Ph.Eur., 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 50% (45/55) 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 want to learn more about 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 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 for Benzalkonium Chloride Solution 50% (45/55) Ph.Eur., USP/NF

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: 42.5 – 47.5% w/w, C14: 52.5 – 57.5% 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: 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 and 25kg 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.

For more information about our Benzalkonium Chloride (BAC / BAK / BKC) products, click here. In case of questions about price and delivery, please contact us for information.