Erythromycin Topical Solution
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This article is compiled based on the United States Pharmacopeia (USP) – 2025 Edition
Issued and maintained by the United States Pharmacopeial Convention (USP)
Erythromycin Topical Solution is a solution of Erythromycin in a suitable vehicle. It contains not less than 90.0 percent and not more than 125.0 percent of the labeled amount of C37H67NO13.
Packaging and storage-Preserve in tight containers.
USP REFERENCE STANDARDS (11)-
USP Erythromycin RS
Identification-Prepare a test solution by mixing a portion of the Topical Solution with methanol to obtain a concentration of about 2.5 mg of erythromycin per mL Proceed as directed in the Identification test under Erythromycin Delayed-Release Capsules, beginning with "Prepare a Standard solution of USP Erythromycin RS."
WATER DETERMINATION, Method 1 (921): not more than 8.0% if it contains 20 mg per mL, or not more than 5.0% if it contains 15 mg per mL, or not more than 2.0% if it contains acetone, 20 mL of a mixture of pyridine and methanol (1:1) being used in place of methanol in the titration vessel.
ALCOHOL DETERMINATION, Method II (611): between 92.5% and 107.5% of the labeled amount of C2H5OH.
Assay-Proceed as directed under Antibiotics-Microbial Assays (81), using an accurately measured volume of Topical Solution diluted quantitatively with Buffer B.3 to yield a Test Dilution having a concentration assumed to be equal to the median dose level of the Standard.
