Hydrocortisone Acetate Cream

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 

Hydrocortisone Acetate Cream is Hydrocortisone Acetate in a suitable cream base. It contains NLT 90.0% and NMT 110.0% of the labeled amount of hydrocortisone acetate (C₂₃H₃₂O₆). 

2 IDENTIFICATION 

Thin-Layer Chromatographic Identification Test 〈201〉 

Standard solution: 250 µg/mL of USP Hydrocortisone Acetate RS in methanol 

Sample solution: To 1 g of Cream add 40.0 mL of a 35% solution of acetonitrile in methanol, and shake until dissolved. To 20.0 mL of this solution add 10.0 mL of isooctane, and mix. Allow the layers to separate, and use the bottom layer. 

Developing solvent system: Ethyl acetate, toluene, and acetone (140:40:13) 

Analysis: Heat the prepared chromatographic plate at 105° for 10 min, and cool. Develop in the Developing solvent system in a paper-lined 

chromatographic chamber equilibrated in an atmosphere of ammonia vapor. 

Acceptance criteria: Meets the requirements 

3 ASSAY 

Procedure 

Mobile phase: Butyl chloride, water-saturated butyl chloride, tetrahydrofuran, methanol, and glacial acetic acid (475:475:70:35:30) Standard solution: 0.10 mg/mL of USP Hydrocortisone Acetate RS in Mobile phase 

Sample solution: Transfer a quantity of Cream, nominally equivalent to 25 mg of hydrocortisone acetate, to a suitable container, add 100.0 mL of tetrahydrofuran, and shake until the Cream dissolves. Transfer 10.0 mL of the resulting solution to another container, and add 15.0 mL of Mobile phase. 

Chromatographic system 

(See Chromatography 〈621〉, System Suitability.) 

Mode: LC 

Detector: UV 254 nm 

Column: 3.9-mm × 30-cm; 10-µm packing L3 

Flow rate: 1 mL/min 

Injection volume: 10 µL 

System suitability 

Sample: Standard solution 

Suitability requirements 

Tailing factor: NMT 2.0 

Relative standard deviation: NMT 2.0% 

Analysis 

Samples: Standard solution and Sample solution 

Calculate the percentage of the labeled amount of hydrocortisone acetate (C₂₃H₃₂O₆) in the portion of Cream 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 Hydrocortisone Acetate RS in the Standard solution (mg/mL)  

C_U = nominal concentration of hydrocortisone acetate in the Sample solution (mg/mL) 

Acceptance criteria: 90.0%–110.0% 

4 PERFORMANCE TESTS 

Minimum Fill 〈755〉: Meets the requirements 

5 SPECIFIC TESTS 

Microbial Enumeration Tests 〈61〉andTests for Specified Microorganisms 〈62〉: It meets the requirements of the tests for the absence of Staphylococcus aureus and Pseudomonas aeruginosa. 

6 ADDITIONAL REQUIREMENTS 

Packaging and Storage: Preserve in well-closed containers. 

USP Reference Standards 〈11〉 

USP Hydrocortisone Acetate RS