Key Properties of Fluticasone Propionate
| Product Name: | Fluticasone Propionate |
| Synonyms: | S-(fluoromethyl) 6α,9-difluoro-11β-hydroxy-16α-methyl-3-oxo-17α-propionyloxyandrosta-1,4-diene-17β-carbothioate |
| CAS No: | 80474-14-2 |
| Chemical Formula: | C₂₅H₃₁F₃O₅S |
| Grade: | EP/BP |
| Appearance: | White to off-white crystalline powder |
| Molar Mass: | 500.57 g/mol |
| Solubility: | Practically insoluble in water, but soluble in dimethyl sulfoxide (DMSO) and slightly soluble in methanol and ethanol. |
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BroucherManufacturing process of Fluticasone Propionate
Before starting the process, equipment cleanliness and material availability are ensured.
Charge Acetone is into the Glass line reactor (GLR), and the precursor with a propionylating agent is added under stirring. Heat the reaction mass up to 50–55°C and maintain the reaction mass at 50–55°C for 240–360 minutes.
Take the in-process sample from reactor and send the In-process sample to Quality control (QC) for reaction monitoring by HPLC. After in-process result complies cool the reaction mass up to 20–25°C, and an anti-solvent like water is added to initiate crystallization.
The crystallized product is filtered through centrifugation operation and washed with chilled water to remove impurities. The product is dried in a vacuum dryer at 40–45°C for 480–600 minutes. After drying, it is milled and sieved to a uniform particle size.
Pack Fluticasone 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 Fluticasone Propionate in a tightly closed, light-resistant container at a temperature of 20°C to 25°C.
Applications of Fluticasone Propionate
Technical Specifications of Fluticasone Propionate
| Sr.No. | Test | Specification |
|---|---|---|
| 1 | Description | A white or almost white powder |
| 2 | Solubility | Practically insoluble in water, sparingly soluble in methylene chloride, slightly soluble in ethanol |
| 3 | Identification by IR | Sample IR should concord with standard IR |
| 4 | Identification by HPLC | The retention time of the major peak of the sample solution corresponds to the standard solution |
| 5 | Specific Optical Rotation | +32° to +36° |
| 6 | Acetone Limit | Not more than 1.0% |
| 7 | Water Content | Not more than 0.5% |
| 8 | Organic Impurities by HPLC | Impurity C: Not more than 0.20% Impurity D: Not more than 0.30% Impurity G: Not more than 0.30% Sum of Impurity J & K: Not more than 0.15% Unspecified Impurity: Not more than 0.10% Total Impurities: Not more than 0.80% |
| 9 | Assay | 97.5% to 102.0% |
Packing and Storage condition of Fluticasone Propionate
Pack Fluticasone 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 Fluticasone Propionate in a tightly closed, light-resistant container at a temperature of 20°C to 25°C.
Why Choose Chemignition for
Fluticasone Propionate Supply?
Quality Assurance
Grade Compliance
Fluticasone 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
Fluticasone 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.
