Benzalkonium Chloride Solution
»Benzalkonium Chloride Solution contains not less than 95.0percent and not more than 105.0percent of the labeled amount of benzalkonium chloride in concentrations of 1.0percent or more;and not less than 93.0percent and not more than 107.0percent of the labeled amount in concentrations of less than 1.0percent.It may contain a suitable coloring agent and may contain not more than 10percent of alcohol.
Caution—Mixing 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.
Identification—
A: It responds toIdentification testsAandCunderBenzalkonium Chloride.
B: The residue obtained by evaporating,on a steam bath,a volume of Solution equivalent to about 200mg of benzalkonium chloride responds toIdentification testBunderBenzalkonium Chloride.
Microbial limits á61ñ— Solution containing less than 5.0%of benzalkonium chloride meets the requirements of the test for absence ofPseudomonas aeruginosa.
Alcohol content ,Method Iá611ñ(if present): between 95.0%and 105.0%of the labeled amount of C2H5OHis found.
Limit of foreign amines— Avolume of Solution,equivalent to 100mg of benzalkonium chloride,and adjusted to a concentration of 1in 50,meets the requirements of the test forForeign amines underBenzalkonium Chloride.
Ratio of alkyl components—
Mobile phase,Standard preparation,Chromatographic system,and Procedure— Proceed as directed in the test forRatio of alkyl components underBenzalkonium Chloride.
Test preparation— Transfer an accurately measured volume of Solution,equivalent to about 400mg of benzalkonium chloride,to a 100-mLvolumetric flask,dilute with water to volume,and mix.
Assay— Evaporate or dilute with water to about 30mLan accurately measured volume of Solution,equivalent to about 275mg of benzalkonium chloride.Transfer the solution with the aid of a minimum quantity of water to a glass-stoppered,250-mLconical separator.Add 25mLof chloroform,and proceed as directed in theAssay for total alkylbenzyldimethylammonium chlorides underBenzalkonium Chloride,beginning with “Add 10.0mLof freshly prepared potassium iodide solution (1in 20).”
Auxiliary Information— Staff Liaison:Daniel K.Bempong,Ph.D.,Scientist
Expert Committee:(EMC)Excipients:Monograph Content
USP28–NF23Page 2964
Pharmacopeial Forum:Volume No.27(5)Page 3059
Phone Number:1-301-816-8143