Sterile Vancomycin Hydrochloride
» Sterile Vancomycin Hydrochloride has a potency equivalent to not less than 900 µg of vancomycin per mg, calculated on the anhydrous basis. In addition, where packaged for dispensing, it contains the equivalent of not less than 90.0 percent and not more than 115.0 percent of the labeled amount of vancomycin.
Constituted solution—
At the time of use, it meets the requirements for Constituted Solutions under Injections 
1
.
1.
Bacterial endotoxins 85—
It contains not more than 0.33 USP Endotoxin Unit per mg of vancomycin hydrochloride.
85—
It contains not more than 0.33 USP Endotoxin Unit per mg of vancomycin hydrochloride.
Sterility 71—
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.
71—
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 788:
meets the requirements under small-volume injections.
788:
meets the requirements under small-volume injections.
Heavy metals, Method II 231:
not more than 0.003%.
231:
not more than 0.003%.
Other requirements—
It responds to the Identification test and meets the requirements of the tests for pH, Water, and Chromatographic purity under Vancomycin Hydrochloride. It meets also the requirements for Uniformity of Dosage Units 905 and for Labeling under Injections 1.
905 and for Labeling under Injections 1.
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 1 mg of vancomycin per mL.
Assay preparation 2
(where it is packaged for dispensing)—Dissolve the contents of 1 container of Sterile Vancomycin Hydrochloride in water, and dilute quantitatively with water to obtain a solution having a concentration of 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 1 container 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 1 mg of vancomycin per mL.
Procedure—
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.
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.
Auxiliary Information—
Please check for your question in the FAQs before contacting USP.
Chromatographic Column—
| Topic/Question | Contact | Expert Committee |
| Monograph | Ahalya Wise, M.S.
Scientist 1-301-816-8161 |
(MDANT05) Monograph Development-Antibiotics |
| Reference Standards | Lili Wang, Technical Services Scientist 1-301-816-8129 RSTech@usp.org |
|
| 85 |
Radhakrishna S Tirumalai, Ph.D.
Senior Scientist 1-301-816-8339 |
(MSA05) Microbiology and Sterility Assurance |
| 71 |
Radhakrishna S Tirumalai, Ph.D.
Senior Scientist 1-301-816-8339 |
(MSA05) Microbiology and Sterility Assurance |
USP32–NF27 Page 3848
Pharmacopeial Forum: Volume No. 34(1) Page 112
Chromatographic columns text is not derived from, and not part of, USP 32 or NF 27.