Packaging and storage
Preserve in Containers for Sterile Solids
as described under Injections 1
At the time of use, it meets the requirements for Constituted Solutions
under Injections 1
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.
Heavy metals, Method II 231:
not more than 0.003%.
, Solution A, Solution B, Mobile phase, Resolution solution, and Chromatographic systemPrepare as directed in the test for Chromatographic purity under Vancomycin Hydrochloride.
Test preparation A
Prepare a solution of Vancomycin Hydrochloride for Injection in Solution A containing 10 mg of vancomycin per mL.
Test preparation B
Transfer 2.0 mL of Test preparation A to a 50-mL flask, dilute with Solution A to volume, and mix.
Proceed as directed for Procedure under Vancomycin Hydrochloride. Not less than 88.0% of vancomycin B is found, and not more than 4.0% of any peak other than the main peak is found.
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 1 mg 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 1 mg 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 1 mg of vancomycin per mL.
Proceed as directed under Antibiotics
Microbial Assays 81
, using an accurately measured volume of the appropriate Assay preparation
diluted quantitatively with Buffer No. 4
to yield a Test Dilution
having a concentration assumed to be equal to the median dose level of the Standard.
: Brian D. Gilbert, Ph.D., Scientist
Expert Committee : (MDANT05) Monograph Development-Antibiotics
USP29NF24 Page 2240
: Volume No. 27(4) Page 2785
Phone Number : 1-301-816-8223