Hydrocortisone Compounded Oral Suspension

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 Compounded Oral Suspension contains NLT 90.0% and NMT 110.0% of the labeled amount of hydrocortisone (C₂₁H₃₀O₅). 

Prepare Hydrocortisone Compounded Oral Suspension, 2 mg/mL, as follows1 (see Pharmaceutical Compounding—Nonsterile Preparations 〈795〉). 

^a Perrigo, Allegan, MI. 

Place the Hydrocortisone powder in a suitable container. Add a small amount of Ora-Blend and mix well to form a smooth paste. Add a sufficient amount of Ora-Blend to make the contents pourable. Transfer contents stepwise and quantitatively to a calibrated container using Ora-Blend. Add sufficient Ora-Blend to bring to nal volume and mix well. 

2 ASSAY 

Procedure 

Solution A: A solution of 5.44 g/L of potassium phosphate dibasic in water, adjusted with phosphoric acid to a pH of 7.5. Pass through a polyvinyl difluoride filter of 0.22-µm pore size. 

Solution B: Methanol and acetonitrile (50:50) 

Diluent: Methanol and water (20:80) 

Mobile phase: See Table 1. 

Table 1 

Standard solution: 0.1 mg/mL of USP Hydrocortisone RS in Diluent. Sonicate for 10 min and vortex. 

Sample solution: Vortex the bottle for 2 min, then allow 1 min for the bubbles to dissipate. Transfer about 2 mL of Oral Suspension into a plastic cup. Draw 1 mL of Oral Suspension into a wide bore micropipette, wipe the outside of the pipette tip, and transfer the sample slowly into a 20-mL volumetric flask. Rinse the pipette tip three times using the Diluent and transfer the contents into the volumetric flask. Dilute with Diluent to volume. Vortex for 2 min and sonicate for 5 min. Vortex for 2 min. Pass through a filter of 0.22-µm pore size and transfer into an HPLC vial after discarding the first 3 mL. 

Chromatographic system 

(See Chromatography 〈621〉, System Suitability.) 

Mode: LC 

Detector: UV 254 nm 

Column: 4.6-mm × 15-cm; 5-µm packing L7 

Temperatures 

Autosampler: 4° 

Column: 30° 

Flow rate: 1 mL/min 

Injection volume: 20 µL 

System suitability 

Sample: Standard solution 

[Note—The retention time for hydrocortisone is about 11.9 min.] 

Suitability requirements 

Tailing factor: NMT 2.0 

Relative standard deviation: NMT 2.0% for replicate injections 

Analysis 

Samples: Standard solution and Sample solution 

Calculate the percentage of the labeled amount of hydrocortisone (C₂₁H₃₀O₅) in the portion of Oral Suspension taken:

Result = (r_U/r_S) × (C_S/C_U) × 100 

r_U = peak response of hydrocortisone from the Sample solution  

r_S = peak response of hydrocortisone from the Standard solution 

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

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

Acceptance criteria: 90.0%–110.0% 

3 SPECIFIC TESTS 

pH 〈791〉: 3.8–4.8 

Appearance: Cloudy, white suspension with visible particulates 

4 ADDITIONAL REQUIREMENTS 

Packaging and Storage: Package in tight, light-resistant containers. Store in a refrigerator or at controlled room temperature. Beyond-Use Date: NMT 90 days after the date on which it was compounded when stored at controlled room temperature or in a refrigerator. Labeling: Label it to indicate that it is to be well shaken before use, and to state the Beyond-Use Date. 

USP Reference Standards 〈11〉 

USP Hydrocortisone RS 

¹ This formulation meets the requirements in Antimicrobial Effectiveness Testing 〈51〉.