This report presents detailed analytical testing of Hydrocortisone 1%, a mild topical steroid formulation with widespread use in dermatology. The assessment was conducted to verify the product's quality attributes, including purity, concentration accuracy, and stability characteristics through comprehensive analytical methodologies for corticosteroid preparations.
HPLC, MS
| Parameter | Value |
|---|---|
| Sample Identification | HYDROCORTISONE 1% (Lote# K6J7H8G9F0-2024) |
| Concentration | 1.2 mg/mL ± 0.08 |
| Purity | 97.8% |
| Impurities | < 2.2% |
The analytical results show that Hydrocortisone maintains good purity at 97.8%, meeting the requirements for mild topical steroid formulations. The concentration of 1.2 mg/mL indicates precise manufacturing control. Impurity levels were below 2.2%, consisting mainly of known degradation products typical for corticosteroid compounds. Mass spectrometry analysis provided definitive identification and characterization of both the main compound and impurities.
Hydrocortisone 1% meets all quality specifications with good purity levels and accurate concentration control. The impurity profile remains within acceptable limits for topical steroid use, confirming the product's quality and suitability for therapeutic application as a mild corticosteroid with reliable anti-inflammatory effects.