Sterile Vancomycin Hydrochloride
»Sterile Vancomycin Hydrochloride has a potency equivalent to not less than 900µg of vancomycin per mg,calculated on the anhydrous basis.In addition,where packaged for dispensing,it contains the equivalent of not less than 90.0percent and not more than 115.0percent of the labeled amount of vancomycin.
Packaging and storage— Preserve in Containers for Sterile Solidsas described under Injections á1ñ.
Constituted solution— At the time of use,it meets the requirements for Constituted Solutionsunder Injections á1ñ.
Bacterial endotoxins á85ñ— It contains not more than 0.33USP Endotoxin Unit per mg of vancomycin hydrochloride.
Sterility á71ñ— It meets the requirements when tested as directed for Membrane Filtration under Test for Sterility of the Product to be Examined,except to dissolve the specimen in water,instead of in Fluid A.
Particulate matter á788ñ: meets the requirements under small-volume injections.
Heavy metals,Method IIá231ñ: not more than 0.003%.
Other requirements— It responds to the Identificationtest and meets the requirements of the tests for pH,Water,and Chromatographic purityunder Vancomycin Hydrochloride.It meets also the requirements for Uniformity of Dosage Units á905ñand for Labelingunder Injections á1ñ.
Assay—
Assay preparation 1— Dissolve a suitable quantity of Sterile Vancomycin Hydrochloride,accurately weighed,in water,and dilute quantitatively with water to obtain a solution containing about 1mg of vancomycin per mL.
Assay preparation 2 (where it is packaged for dispensing)—Dissolve the contents of 1container of Sterile Vancomycin Hydrochloride in water,and dilute quantitatively with water to obtain a solution having a concentration of about 1mg of vancomycin per mL.
Assay preparation 3 (where the label states the quantity of vancomycin in a given volume of constituted solution)—Constitute 1container of Sterile Vancomycin Hydrochloride in a volume of water,accurately measured,corresponding to the volume of solvent specified in the labeling.Dilute an accurately measured volume of the constituted solution quantitatively with water to obtain a solution having a concentration of about 1mg of vancomycin per mL.
Procedure— Proceed as directed under Antibiotics—Microbial Assays á81ñ,using an accurately measured volume of the appropriate Assay preparationdiluted quantitatively with Buffer No.4to yield a Test Dilutionhaving a concentration assumed to be equal to the median dose level of the Standard.
Auxiliary Information— Staff Liaison:William W.Wright,Ph.D.,Scientific Fellow
Expert Committee:(PA7)Pharmaceutical Analysis 7
USP28–NF23Page 2015
Pharmacopeial Forum:Volume No.27(4)Page 2786
Phone Number:1-301-816-8335