BKC

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

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

CAS No. 8001-54-5.

Our Benzalkonium Chloride (BAC / BAK / BKC) consists of Benzyl (dodecyl) dimethyl ammonium chloride (approx. 65%) and Benzyl (tetradecyl) dimethyl ammonium chloride (approx. 35%). Contains approx. 95% active ingredients.

BKC is manufactured in accordance with the cGMP Guideline ICH Q7 for Active Pharmaceutical Ingredients. Analyzed according to the current European (Ph.Eur.) and the United States (USP/NF) Pharmacopoeias. Now also analysed according to the Chinese Pharmacopoeia (ChP).

The appearance of the product is clear, or white to yellowish-white solid or viscous liquid and may contain yellowish-white fragments. The density of Benzalkonium Chloride (BKC) is approx. 0.98 g/ml.

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

Application

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

FeF BKC 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 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 much more about uses and the applications here.

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Packing Sizes
Item no.
Product image
Packing Sizes
1 kg bottle
Item no.
7800014
Product image
7800014
Packing Sizes
5 kg pail
Item no.
7800015
Product image
7800015

All deliveries of Benzalkonium Chloride (BKC) 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), Ph.Eur., USP/NF

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

Appearance/Clarity of solution: Max. as ref. susp. I / Max. as ref. 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/ Ammonium compounds: Max. 1.0 ml/g

Water: Max 10.0% w/w

Sulphated ash/Residue on ignition: Max. 0.1% w/w

Water-insoluble matter: No turbidity and insoluble matter

Assay (anhydrous basis): Ph.Eur.: 95.0 – 104.0% w/w USP/NF: 97.0 – 103.0% w/w CHP: 95.0 – 105.0% w/w

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 is packaged in rectangular HDPE plastic containers with tamper proof LDPE Caps. 5 kg is packaged in round PP plastic containers with tamper proof PP lids.

Shelf life: 5 years.

Storage: Store at temperatures above 15°C. Store protected from excessive heat. May be a liquid, paste or solid depending on the storage conditions.

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

Mette Borgaard
Customer Support Assistant

Phone: +45 2429 4134
Email: nnprinfo@novonordisk.com