FeF Benzalkonium Chloride (BKC) 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 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.
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
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.