Cortisone Acetate

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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C₂₃H₃₀0₆        402.48

Pregn-4-ene-3,11,20-trione, 21-(acetyloxy)-17-hydroxy-;

17,21-Dihydroxypregn-4-ene-3,11,20-trione 21-acetate CAS RN^®: 50-04-4; UNII: 883WKN7W8X.

1 DEFINITION

Cortisone Acetate contains NLT 97.0% and NMT 102.0% of cortisone acetate (C₂₃H₃₀0₆), calculated on the dried basis.

2 IDENTIFICATION

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A. ^▲▲SPECTROSCOPIC IDENTIFICATION TESTS (197), Infrared Spectroscopy: 197K _{▲(CN1-MAY-2020)}: [NOTE-Methods described in (197K) or (1974), may be used.] _{▲2S (USP41)}

Sample: Dissolve in methanol, evaporate the methanol on a steam bath, and dry at 105° for 30 min.

Acceptance criteria: Meets the requirements

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B. ^▲The retention time of the major peak of the Sample solution corresponds to that of the Standard solution, as obtained in the Assay 25 _▲(USP41)

3 ASSAY

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3.1 PROCEDURE

Solution A: Water

Solution B: Acetonitrile

Mobile phase: See Table 1.

    Table 1

Diluent: Acetonitrile, glacial acetic acid, and water (70:1:30)

System suitability solution: 1000 µg/mL of USP Cortisone Acetate RS and 150 µg/mL of USP Hydrocortisone Acetate RS in Diluent

Standard solution: 1000 µg/mL of USP Cortisone Acetate RS in Diluent

Sample solution: 1000 µg/mL of Cortisone Acetate in Diluent

3.1.1 Chromatographic system

(See Chromatography (621), System Suitability.)

Mode: LC

Detector: UV 242 nm

Column: 4.0-mm x 10-cm; 3-µm packing L1

Flow rate: 1.5 mL/min

Injection volume: 15 µL

3.1.2 System suitability

[NOTE-See Table 2 for the relative retention times.]

Samples: System suitability solution and Standard solution

3.1.3 Suitability requirements

Resolution: NLT 4.2 between cortisone acetate and hydrocortisone acetate, System suitability solution

Tailing factor: NMT 1.5, Standard solution

Relative standard deviation: NMT 0.73%, Standard solution

3.1.4 Analysis

Samples: Standard solution and Sample solution

Calculate the percentage of cortisone acetate (C₂₃H₃₀0₆) in the portion of Cortisone Acetate taken:

                Result = (r_U/r_S) x (C_S/C_U) × 100

r_U = peak response from the Sample solution

r_S = peak response from the Standard solution S

C_S = concentration of USP Cortisone Acetate RS in the Standard solution (µg/mL)

C_U = concentration of Cortisone Acetate in the Sample solution (µg/mL)_{▲2S (USP41)}

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

4 IMPURITIES

4.1 Change to read:

RESIDUE ON IGNITION (281): ^▲NMT 0.50% _{▲2S (USP41)}

4.2 Change to read:

4.2.1 ORGANIC IMPURITIES

Solution A, Solution B, Mobile phase, Diluent, System suitability solution, Sample solution, and Chromatographic system: Proceed as directed in the Assay.

Standard solution: 1 µg/mL of USP Cortisone Acetate RS and 5 µg/mL of USP Hydrocortisone Acetate RS in Diluent

4.2.1.1 System suitability

[NOTE-See Table 2 for the relative retention times.]

Samples: System suitability solution and Standard solution

4.2.1.2 Suitability requirements

Resolution: NLT 4.2 between cortisone acetate and hydrocortisone acetate, System suitability solution

Relative standard deviation: NMT 5.0%, hydrocortisone acetate and cortisone acetate, Standard solution

Analysis

Samples: Standard solution and Sample solution

Calculate the percentage of hydrocortisone acetate in the portion of Cortisone Acetate taken:

                Result = (r_U/r_S) x (C_S/C_U) × 100

r_U = peak response of hydrocortisone acetate from the Sample solution

r_S = peak response of hydrocortisone acetate from the Standard solution

C_S = concentration of USP Hydrocortisone Acetate RS in the Standard solution (µg/mL)

C_U = concentration of Cortisone Acetate in the Sample solution (µg/mL)

Calculate the percentage of any individual unspecified impurity in the portion of Cortisone Acetate taken:

                Result = (r_U/r_S) x (C_S/C_U) × 1000

r_U = peak response of any individual unspecified impurity from the Sample solution

r_S = peak response of cortisone acetate from the Standard solution

C_S = concentration of USP Cortisone Acetate RS in the Standard solution (µg/mL)

C_U = concentration of Cortisone Acetate in the Sample solution (µg/mL)

Acceptance criteria: See Table 2.

     Table 2

5 SPECIFIC TESTS

5.1 OPTICAL ROTATION (781S), Procedures. Specific Rotation

Sample solution: 10 mg/mL in dioxane

Acceptance criteria: +208° to +217°

5.2 LOSS ON DRYING (731)

Analysis: Dry at 105° for 30 min.

Acceptance criteria: NMT 1.0%

5.3 ADDITIONAL REQUIREMENTS

PACKAGING AND STORAGE: Preserve in well-closed containers. Store at 25°, excursions permitted between 15° and 30°.

Change to read:

USP REFERENCE STANDARDS (11)

USP Cortisone Acetate RS

USP Hydrocortisone Acetate RS2S _▲(USP41)