Baclofen Compounded Oral Suspension

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BRIEFING

Baclofen Compounded Oral Suspension. This proposal is based on the version of the monograph official as of December 1, 2016. Changes are proposed to add a new formula for two different concentrations based on a validated stability-indicating method used for assessing stability. The liquid chromatographic procedure in the Assay is based on analyses validated using the Acquity UPLC BEH C18 brand of analytical column with L1 packing. The typical retention time for baclofen is about 3.1 min.

Additionally, minor editorial changes have been made to update the monograph to current USP style.

Please submit comments to CompoundingSL@usp.org.

(CMP: B. Groat)

Case ID—SUB-145

USP REFERENCE STANDARDS FOR PURCHASE

USP Baclofen RS

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