Vancomycin Hydrochloride for Injection
»Vancomycin Hydrochloride for Injection is a sterile dry mixture of Vancomycin Hydrochloride and a suitable stabilizing agent.It has a potency equivalent to not less than 925µg of vancomycin per mg,calculated on the anhydrous basis.In addition,it contains 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.
Sterility á71ñ— It meets the requirements when tested as directed for Membrane Filtrationunder 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%.
Chromatographic purity—
Triethylamine buffer ,Solution A,Solution B,Mobile phase,Resolution solution,and Chromatographic system—Prepare as directed in the test for Chromatographic purityunder Vancomycin Hydrochloride.
Test preparation A— Prepare a solution of Vancomycin Hydrochloride for Injection in Solution Acontaining 10mg of vancomycin per mL.
Test preparation B— Transfer 2.0mLof Test preparation Ato a 50-mLflask,dilute with Solution Ato volume,and mix.
Procedure— Proceed as directed for Procedureunder Vancomycin Hydrochloride.Not less than 88.0%of vancomycin Bis found,and not more than 4.0%of any peak other than the main peak is found.
Other requirements— It responds to the Identificationtest and meets the requirements of the tests for pHand Waterunder Vancomycin Hydrochloride.It also meets the requirements for Uniformity of Dosage Units á905ñand Labelingunder Injections á1ñ.
Assay—
Assay preparation 1 (for determining the µg of vancomycin equivalent per mg)—Dissolve a suitable quantity of Vancomycin Hydrochloride for Injection,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 represented as being in a single-dose container)—Constitute a container of Vancomycin Hydrochloride for Injection in a volume of water,accurately measured,corresponding to the volume of diluent specified in the labeling.Withdraw all of the withdrawable contents,using a suitable hypodermic needle and syringe,and dilute quantitatively with water to obtain a solution containing 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 a container of Vancomycin Hydrochloride for Injection in a volume of water,accurately measured,equivalent to the volume of diluent specified in the labeling.Dilute an accurately measured volume of the constituted solution quantitatively with water to obtain a solution containing 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 2785
Phone Number:1-301-816-8335