Carbachol Intraocular Solution
»Carbachol Intraocular Solution is a sterile solution of Carbachol in an aqueous medium.It contains not less than 90.0percent and not more than 115.0percent of the labeled amount of C6H15ClN2O2.It contains no preservatives or antimicrobial agents.
Packaging and storage— Preserve in tight containers,at controlled room temperature,and protect from freezing.
Labeling— Label it to indicate that it is for single-dose intraocular use only,and that the unused portion is to be discarded.
Identification— Dilute,if necessary,an accurately measured volume of Intraocular Solution quantitatively and stepwise with water to obtain a solution containing about 100µg of carbachol per mL.Transfer 5mLof this test solution to a 125-mLseparator.To another separator,add 5mLof water to provide a blank.To each separator add 1.0mLof 1Nsodium hydroxide and 2.0mLof a 2in 1000solution of hexanitrodiphenylamine in 0.1Nsodium hydroxide.Mix,add 15mLof methylene chloride to each separator,shake for 1minute,and allow the layers to separate:a deep amber color is produced in the methylene chloride layer obtained from the test solution.
Sterility á71ñ: meets the requirements.
pHá791ñ: between 5.0and 7.5.
Assay—
Hypochlorite reagent and Standard preparation—Prepare as directed in the Assayunder Carbachol Ophthalmic Solution.
Assay preparation— Dilute,if necessary,an accurately measured volume of Intraocular Solution quantitatively and stepwise with water to obtain a solution containing about 100µg of carbachol per mL.
Procedure— Proceed as directed for Procedurein the Assayunder Carbachol Ophthalmic Solution.
Auxiliary Information— Staff Liaison:Salvador C.Salado,M.S.,Scientist and Latin American Liaison
Expert Committee:(PA3)Pharmaceutical Analysis 3
USP28–NF23Page 340
Phone Number:1-301-816-8165