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.
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.
pH 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%.
Assay— Proceed as directed under Antibiotics—Microbial Assays 81, 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— Please check for your question in the FAQs before contacting USP.
Topic/Question Contact Expert Committee
Monograph Ahalya Wise, M.S.
(MDANT05) Monograph Development-Antibiotics
Reference Standards Lili Wang, Technical Services Scientist
USP32–NF27 Page 3848
Pharmacopeial Forum: Volume No. 30(1) Page 193