Fentanyl Citrate Compounded Injection

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BRIEFING

Fentanyl Citrate Compounded Injection. This proposal is based on the version of the monograph official as of May 1, 2020. Changes are being proposed to correct the molecular weight conversion of fentanyl to fentanyl citrate, add further criteria to Bacterial Endotoxins Test 〈85〉 and the Appearance test in Specific Tests, and revise the language in the Packaging and Storage and Beyond-Use Date sections.

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)

Correspondence Number—C325483

USP REFERENCE STANDARDS FOR PURCHASE

USP Fentanyl Citrate RS

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