BKC 50%

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

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

CAS No. 8001-54-5

Our Benzalkonium Chloride (BAC / BAK / BKC) 50% consists of Benzyl (dodecyl) dimethyl ammonium chloride (approx. 65%) and Benzyl (tetradecyl) dimethyl ammonium chloride (approx. 35%). Contains approx. 50% active ingredients.

BKC 50% is 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 Solution 50% is approx. 0.98 g/ml.

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

You can find our other BKC 50% products here:

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

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

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

Application

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

FeF BKC 50% 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% 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.

You can read more about the applications and uses here.

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Packing Sizes
Item no.
Product image
Packing Sizes
1 kg bottle
Item no.
7800004
Product image
7800004
Packing Sizes
5 kg bottle
Item no.
7800005
Product image
7800005
Packing Sizes
25 kg jug
Item no.
7800006
Product image
7800006
Packing Sizes
1000 kg IBC
Item no.
7800027
Product image
7800027

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 for Benzalkonium Chloride (BKC) Solution 50%, 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: 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: 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: 1 kg, 5 kg and 25 kg are packaged in rectangular HDPE containers with tamper proof HDPE caps. 1000 kg is packaged in a HDPE bulk container (IBC) 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 find more information about our Benzalkonium Chloride (BAC / BAK / BKC) products here. Please contact us for information about price and delivery.

Margrethe Fischer Henrichsen
Customer Support Assistant

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