Cortisone Acetate Tablets

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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1 DEFINITION

Cortisone Acetate Tablets contain NLT 90.0% and NMT 110.0% of the labeled amount of cortisone acetate (C₂₃H₃₀0₆).

2 IDENTIFICATION

2.1 Change to read:

A. ^▲SPECTROSCOPIC IDENTIFICATION TESTS (197), Infrared Spectroscopy: 197K ▲_{(CN 1-MAY-2020)}

Sample: Powder a number of Tablets equivalent to 25 mg of cortisone acetate. Add 25 mL of solvent hexane, and extract for 15 min with occasional agitation. Decant and discard the supernatant, then extract the residue with 5 mL of chloroform, with frequent agitation, for 5 min. Filter, add 10 mL of methanol to the filtrate, mix, evaporate the solvent on a steam bath with the aid of a current of air, then dry the residue at 105° for 30 min. Use the residue.

Acceptance criteria: Meet the requirements

2.2 Add the following:

B. The retention time of the major peak of the Sample solution corresponds to that of the Standard solution, as obtained in the Assay._{▲2S (USP41)}

3 ASSAY

Change to read:

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: Nominally 1000 µg/mL of cortisone acetate from Tablets in Diluent, prepared as follows. Transfer an appropriately weighed portion of finely powdered Tablets (NLT 20) to a suitable volumetric flask. Add 80% of the final flask volume of Diluent and sonicate for 10 min. Dilute with Diluent to volume and mix well. Pass through a suitable filter of 0.2-µm pore size.

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 1.0%, Standard solution

3.1.4 Analysis

Samples: Standard solution and Sample solution

Calculate the percentage of the labeled amount of cortisone acetate (C₂₃H₃₀0₆) in the portion of Tablets taken:

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

r_U = peak response from the Sample solution r_{u} = 1

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 = nominal concentration of cortisone acetate in the Sample solution (µg/mL) _{▲2S (USP41)}

Acceptance criteria: 90.0%-110.0%

4 PERFORMANCE TESTS

4.1 Change to read:

4.1.1 DISSOLUTION (711).

Medium: 0.5% sodium lauryl sulfate solution; 1000 mL

Apparatus 2: 50 rpm

Apparatus 2: 50 rpm

Time: 45 min

Standard solution: ^▲0.00555 mg/mL_{▲2S (USP41)} of USP Cortisone Acetate RS in Medium

Sample solution: Pass a portion of the solution under test through a suitable filter. Dilute with Medium, if necessary.

4.1.1.1 Instrumental conditions

Mode: UV

Analytical wavelength: Maximum absorbance at about 242 nm

Cell: 1 cm

4.1.1.2 Analysis

Samples: Standard solution and Sample solution

Calculate the percentage of the labeled amount of cortisone acetate (C₂₃H₃₀0₆) dissolved:

                Result = (A_U/A_S) x C_S x V x D x (1/L) x 100

A_U = absorbance of the Sample solution

A_S = absorbance of the Standard solution

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

V = volume of Medium, 1000 mL

D = dilution factor for the Sample solution, if applicable

L = label claim (mg/Tablet)_{▲2S (USP41)}

Tolerances: NLT 75% (Q) of the labeled amount of cortisone acetate (C₂₃H₃₀0₆) is dissolved.

4.2 Change to read:

UNIFORMITY OF DOSAGE UNITS (905): ^▲Meet the requirements _{▲2S (USP41)}

5 IMPURITIES

5.1 Add the following:

5.1.1 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: 5 µg/mL of USP Cortisone Acetate RS in Diluent

5.1.1.1 System suitability

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

Samples: System suitability solution and Standard solution

Suitability requirements

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

Relative standard deviation: NMT 5.0%, Standard solution

5.1.1.2 Analysis

Samples: Standard solution and Sample solution

Calculate the percentage of any individual unspecified degradation product in the portion of Tablets taken:

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

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

r_S = peak response of cortisone acetate from the Standard solution s

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

C_U = nominal concentration of cortisone acetate in the Sample solution (µg/mL)

Acceptance criteria: See Table 2.

   Table 2

^a Process impurity included in the table for identification only. Process impurities are controlled in the drug substance, and are not to be reported or included in the total impurities for the drug product.

2S (USP41)

5.2 ADDITIONAL REQUIREMENTS

PACKAGING AND STORAGE: Preserve in well-closed containers.

Change to read:

USP REFERENCE STANDARDS (11)

USP Cortisone Acetate RS

USP Hydrocortisone Acetate RS2S (USP41)