Prednicarbate

This article is compiled based on the United States Pharmacopeia (USP) – 2025 Edition

Issued and maintained by the United States Pharmacopeial Convention (USP)

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C₂₇H₃₆O₈  488.57

Pregna-1,4-diene-3,20-dione, 17-[(ethoxycarbonyl)oxy]-11-hydroxy-21-(1-oxopropoxy)-, (11β)-;

11β,17,21-Trihydroxypregna-1,4-diene-3,20-dione 17-(ethyl carbonate) 21-propionate  CAS RN^®: 73771-04-7; UNII: V901LV1K7D.

1 DEFINITION

Prednicarbate contains NLT 97.0% and NMT 102.0% of prednicarbate (C₂₇H₃₆O₈), calculated on the dried basis.

2 IDENTIFICATION

Change to read:

A. Spectroscopic Identification Tests 〈197〉, Infrared Spectroscopy: 197K (CN 1-May-2020)

B. The retention time of the major peak of the Sample solution corresponds to that of the Standard solution, as obtained in the Assay.

3 ASSAY

3.1 Procedure

Prepare all solutions just before use.

Mobile phase: Acetonitrile and water (50:60)

System suitability solution: 3 µg/mL each of USP Prednicarbate RS and USP Prednicarbate Related Compound A RS in Mobile phase.

Standard solution: 0.6 mg/mL of USP Prednicarbate RS in Mobile phase

Sample solution: 0.6 mg/mL of Prednicarbate in Mobile phase

Chromatographic system

(See Chromatography 〈621〉, System Suitability.)

Mode: LC

Detector: UV 243 nm

Column: 4-mm × 12.5-cm; packing L1

Flow rate: 0.7 mL/min

Injection volume: 20 µL

Run time: 2 times the retention time of prednicarbate

System suitability

Sample: System suitability solution

[Note—See Table 1 for the relative retention times.]

Suitability requirements

Resolution: NLT 3.0 between prednicarbate and prednicarbate related compound A

Analysis

Samples: Standard solution and Sample solution

Calculate the percentage of prednicarbate (C₂₇H₃₆O₈) in the portion of Prednicarbate taken:

Result = (r_U/r_S) × (C_S/C_U) × 100

r_U = peak response from the Sample solution

r_S = peak response from the Standard solution

C_S = concentration of USP Prednicarbate RS in the Standard solution (mg/mL)

C_U = concentration of Prednicarbate in the Sample solution (mg/mL)

Acceptance criteria: 97.0%–102.0% on the dried basis 

4 IMPURITIES

4.1 Organic Impurities

Mobile phase, System suitability solution, Chromatographic system, and System suitability: Proceed as directed in the Assay.

Sample stock solution: 0.6 mg/mL of Prednicarbate in Mobile phase

Sample solution: 3 µg/mL of Prednicarbate in Mobile phase from the Sample stock solution

Analysis

Samples: Sample stock solution and Sample solution

Calculate the percentage of each individual impurity in the portion of Prednicarbate taken:

Result = (r_UA/r_UB) × D × 100

r_UA = peak response for each individual impurity from the Sample stock solution

r_UB = peak response of prednicarbate from the Sample solution

D = dilution factor for the Sample solution

Acceptance criteria: See Table 1.

Disregard any peak with an area less than 0.025 times the area of the main peak from the Sample solution (0.0125%).

Table 1

5 SPECIFIC TESTS

5.1 Optical Rotation, Specific Rotation 〈781S〉

Sample solution: 10 mg/mL in alcohol

Acceptance criteria: +60° to +66°

5.2 Loss on Drying 〈731〉

Analysis: Dry at 105° for 6 h.

Acceptance criteria: NMT 0.5%

6 ADDITIONAL REQUIREMENTS

Packaging and Storage: Preserve in well-closed, light-resistant containers.

USP Reference Standards 〈11〉

USP Prednicarbate RS

USP Prednicarbate Related Compound A RS

1,2-Dihydroprednicarbate.