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Active Pharmaceuticals

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  • Specifications
  • Product Description
  • Product Usage
  • COA
Product Name Clobetasol Propionate
CAS No. 25122-46-7
Purity 99%
Grade Standard Medical Standard
MF C25H32ClFO5
MW 466.97
Appearance White Powder

Clobetasol propionate is a dermatological drug. External application is suitable for chronic eczema, neurodermatitis, psoriasis, palmoplantar pustulosis, lichen planus, discoid lupus erythematosus and other glucocorticoids for topical treatment of effective pruritic and non-infectious inflammatory skin diseases.

Clobetasol Propionate is the propionate salt form of clobetasol, a topical synthetic corticosteroid with anti-inflammatory, anti-pruritic, and vasoconstrictive properties. Clobetasol propionate exerts its effect by binding to cytoplasmic glucocorticoid receptors and subsequently activates glucocorticoid receptor mediated gene expression. This results in the synthesis of certain anti-inflammatory proteins, while inhibiting the synthesis of certain inflammatory mediators. Specifically, clobetasol propionate appears to induce phospholipase A2 inhibitory proteins, thereby controlling the release of the inflammatory precursor arachidonic acid from membrane phospholipids by phospholipase A2.

Item

Standard

Result
Appearance White or almost White crystalline powder. White crystalline powder
Identification Conforms to the CRS spectrum. Conforms
Specific optical rotation +112°~ +118°(dried substance) +113.5°
Related substances

(by HPLC)

Impurity A 0.2% max 0.07%
Impurity B 0.3% max 0.08%
Impurity C 0.2% max Undetected
Impurity D 0.2% max Undetected
Impurity E 0.5% max 0.19%
Impurity L 0.2% max Undetected
Impurity M 0.2% max Undetected
Unspecified impurities 0.1% max 0.08%
Total impurities 1.5% max 0.48%
Loss in drying 0.5% max 0.2%
Sulphated ash 0.1% max 0.07%
Assay(by HPLC) Contains 97.0% to 102.0% of C25H32ClFO5, calculated on dried basis. 99.2%
Residual solvents Ethanol 3000ppm max 69ppm
Ace-tone 500ppm max 4ppm
Py-ridine 100 ppm 3ppm
N,N-Dimethyl formamide 100ppm max 10ppm
Conclusion Meet the specification according to ph.Eur.8

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