USP Monographs: Vancomycin Hydrochloride for Oral Solution

Vancomycin Hydrochloride for Oral Solution

» Vancomycin Hydrochloride for Oral Solution contains the equivalent of not less than 90.0 percent and not more than 115.0 percent of the labeled amount of vancomycin.

Packaging and storage— Preserve in tight containers.

USP Reference standards

— USP Vancomycin Hydrochloride RS.

Uniformity of dosage units

905

—

FOR POWDER PACKAGED IN SINGLE-UNIT CONTAINERS: meets the requirements.

Deliverable volume

698

—

FOR POWDER PACKAGED IN MULTIPLE-UNIT CONTAINERS:

meets the requirements.

791

: between 2.5 and 4.5, for the solution constituted as directed in the labeling.

Water, Method I

921

: not more than 5.0%.

Residual solvents

467

: meets the requirements.

(Official January 1, 2007)

Assay— Proceed as directed under Antibiotics—Microbial Assays

, dissolving the contents of 1 container of Vancomycin Hydrochloride for Oral Solution in water as directed in the labeling. Dilute a portion of this solution quantitatively with Buffer No. 4 to obtain a Test Dilution having a concentration assumed to be equal to the median dose level of the Standard.

Auxiliary Information— Staff Liaison : Brian D. Gilbert, Ph.D., Scientist

Expert Committee : (MDANT05) Monograph Development-Antibiotics

USP29–NF24 Page 2241

Pharmacopeial Forum : Volume No. 30(1) Page 193

Phone Number : 1-301-816-8223


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