USPUSP-NF
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Prednisolone
C21H28O5 (anhydrous) 360.44360.45
 Pregna-1,4-diene-3,20-dione, 11,17,21-trihydroxy-, (11β)-;
 11β,17,21-Trihydroxypregna-1,4-diene-3,20-dione (anhydrous) [50-24-8] C21H28O5·1½H2O (sesquihydrate) 387.48 387.47
 [52438-85-4]

BRIEFING

 Prednisolone. This proposal is based on the version of the monograph official as of June 1, 2023. It is proposed to revise the monograph with the following changes:

  1. Update the molecular weight for anhydrous prednisolone in the Chemical Information section to be consistent with the current IUPAC values.

  2. Revise Identification A to include 197A to allow the flexibility of using either 197A or 197K.

  3. Replace Identification B with the chromatographic retention time agreement of the prednisolone peak of the Sample solution and the Standard solution, based on the proposed Assay.

  4. Replace the current HPLC procedure in the Assay, which uses an internal standard, with a chromatographic procedure similar to that in the proposed Organic Impurities procedure.

  5. Revise the Acceptance criteria in the Residue on Ignition test from negligible to NMT 0.50%, to be consistent with the definition of negligible provided in General Notices, 8.100 Negligible.

  6. Remove the test for Selenium from this monograph because this elemental impurity will be controlled in the drug product using the risk-based approach specified in Elemental Impurities—Limits 〈232〉. The risk-based approach will be used to determine the presence of an elemental impurity (in components of the formulation or in the drug product) and the appropriate level of control. Therefore, it is redundant to include the test and Acceptance criteria for the elemental impurity selenium in this monograph.

  7. Replace the current chromatographic purity procedure in the Organic Impurities test with a validated liquid chromatographic (LC) procedure.

  8. The LC procedure in the Assay and in the test for Organic Impurities was validated using the Poroshell 120 SB-Aq brand of column with L96 packing. The typical retention time for prednisolone is about 15 min.

  9. Add USP Hydrocortisone RS and USP Prednisone RS to the USP Reference Standards section to support the proposed test for Organic Impurities.

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

 (SM5: P. Jagu)

 Correspondence Number—C186486

USP REFERENCE STANDARDS FOR PURCHASE

USP Hydrocortisone RS
USP Prednisolone RS
USP Prednisolone RS
USP Prednisone RS
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