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