Key Properties of Clobetasol Propionate
| Product Name: | Clobetasol Propionate |
| Synonyms: | (11β,16β)-21-Chloro-9-fluoro-11-hydroxy-16-methyl-17-(propionyloxy)-pregna-1,4-diene-3,20-dione |
| CAS No: | 25122-46-7 |
| Chemical Formula: | C25H32ClFO5 |
| Grade: | BP/USP |
| Appearance: | Crystalline powder |
| Molar Mass: | 466.97 g/mol |
| Solubility: | Practically insoluble in water; soluble in methanol, ethanol, acetone, and chloroform |
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BroucherManufacturing process of Clobetasol Propionate
The manufacturing process begins with ensuring equipment cleanliness and availability of utilities, raw materials, and packing materials.
Charge acetone or dichloromethane in to Glass line reactor (GLR). The starting materials, including clobetasol base and the appropriate reagents for esterification, are then charged into the reactor. The reaction mixture is maintained at a temperature of 40–50°C for 360–480 minutes while being stirred constantly to ensure proper conversion.
Once the reaction is complete, the mixture is cooled to 5–10°C to promote the crystallization of Clobetasol Propionate. An anti-solvent is added to aid the crystallization process and ensure efficient precipitation of the product. After crystallization, the product is filtered to separate the crystalline material from the mother liquor. The product is then washed with chilled anti-solvent to remove any residual impurities and enhance its purity.
Following filtration, the wet product is transferred to a vacuum dryer, where it is dried at 40–50°C for 360–480 minutes to remove any remaining solvent or moisture. This drying step is crucial to achieve the desired dryness.
Finally, Pack Clobetasol propionate in a clear poly bag and twist the mouth of the bag. Secure it with a PVC strip. Place this bag inside another poly bag, twist its mouth, and secure it with a PVC strip. Insert these bags into a triple-laminated aluminum bag and seal it properly. Finally, place the sealed aluminum bag in an HDPE container. Store Clobetasol propionate in a tightly closed, light-resistant container at a temperature below 30°C.
Applications of Clobetasol Propionate
Technical Specifications of Clobetasol Propionate
| Sr.No. | Test | Specification |
|---|---|---|
| 1 | Description | White to off-white crystalline powder |
| 2 | Identification by IR | The IR spectrum obtained with the test sample should be concordant with the working standard |
| 3 | Melting Point | About 196°C |
| 4 | Specific Rotation | Between +98° and +104° |
| 5 | Loss on Drying | NMT (Not More Than) 2.0% |
| 6 | Residue on Ignition | NMT 0.1% |
| 7 | Organic Volatile Impurities | Any individual impurity: NMT 1.0% Total impurities: NMT 2.5% |
| 8 | Assay by HPLC | 97.0% to 102.0% |
Packing and Storage condition of Clobetasol Propionate
Pack Clobetasol propionate in a clear poly bag and twist the mouth of the bag. Secure it with a PVC strip. Place this bag inside another poly bag, twist its mouth, and secure it with a PVC strip. Insert these bags into a triple-laminated aluminum bag and seal it properly. Finally, place the sealed aluminum bag in an HDPE container. Store Clobetasol propionate in a tightly closed, light-resistant container at a temperature below 30°C.
Why Choose Chemignition for
Clobetasol Propionate Supply?
Quality Assurance
Grade Compliance
Clobetasol Propionate is manufactured in adherence to stringent global pharmaceutical standards.
In-House Quality Control
Each batch undergoes rigorous testing for purity, stability, and efficacy.
Regulatory Approvals
Certified for export and compliant with international regulatory requirements.
Large-Scale Manufacturing and Export
Grade Compliance
Clobetasol Propionate is manufactured in adherence to stringent global pharmaceutical standards.
In-House Quality Control
Each batch undergoes rigorous testing for purity, stability, and efficacy.
Regulatory Approvals
Certified for export and compliant with international regulatory requirements.
