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.
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.
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
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.