BKC 50%

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

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.

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Packing Sizes
Item no.
Product image
Packing Sizes
1 kg bottle
Item no.
7800008
Product image
7800008

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.

Margrethe Fischer Henrichsen
Customer Support Assistant

Phone: +45 3199 5965
Email: nnprinfo@novonordisk.com

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