Benzalkonium Chloride Solution
» Benzalkonium Chloride Solution contains not less than 95.0 percent and not more than 105.0 percent of the labeled amount of benzalkonium chloride in concentrations of 1.0 percent or more; and not less than 93.0 percent and not more than 107.0 percent of the labeled amount in concentrations of less than 1.0 percent. It may contain a suitable coloring agent and may contain not more than 10 percent of alcohol.
CautionMixing Benzalkonium Chloride Solution with ordinary soaps and with anionic detergents may decrease or destroy the bacteriostatic activity of the Solution.
Packaging and storage Preserve in tight containers, and prevent contact with metals.
USP Reference standards 11
USP Benzalkonium Chloride RS.
A: It responds to Identification tests A and C under Benzalkonium Chloride.
B: The residue obtained by evaporating, on a steam bath, a volume of Solution equivalent to about 200 mg of benzalkonium chloride responds to Identification test B under Benzalkonium Chloride.
Microbial enumeration tests 61 and Tests for specified microorganisms 62 Solution containing less than 5.0% of benzalkonium chloride meets the requirements of the test for absence of Pseudomonas aeruginosa.
Alcohol content, Method I 611 (if present): between 95.0% and 105.0% of the labeled amount of C2H5OH is found.
Limit of foreign amines A volume of Solution, equivalent to 100 mg of benzalkonium chloride, and adjusted to a concentration of 1 in 50, meets the requirements of the test for Foreign amines under Benzalkonium Chloride.
Ratio of alkyl components
Mobile phase, Standard preparation, Chromatographic system, and Procedure Proceed as directed in the test for Ratio of alkyl components under Benzalkonium Chloride.
Test preparation Transfer an accurately measured volume of Solution, equivalent to about 400 mg of benzalkonium chloride, to a 100-mL volumetric flask, dilute with water to volume, and mix.
Assay Evaporate or dilute with water to about 30 mL an accurately measured volume of Solution, equivalent to about 275 mg of benzalkonium chloride. Transfer the solution with the aid of a minimum quantity of water to a glass-stoppered, 250-mL conical separator. Add 25 mL of chloroform, and proceed as directed in the Assay for total alkylbenzyldimethylammonium chlorides under Benzalkonium Chloride, beginning with Add 10.0 mL of freshly prepared potassium iodide solution (1 in 20).
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USP32NF27 Page 1174Pharmacopeial Forum: Volume No. 27(5) Page 3059