Key Properties of Fluticasone furoate
| Product Name: | Fluticasone furoate |
| Synonyms: | (6α,11β,16α,17α)-6,9-Difluoro-17-{(fluoromethyl)sulfanyl}-11-hydroxy-16-methyl-3-oxoandrosta-1,4-dien-17-yl furan-2-carboxylate |
| CAS No: | 397864-44-7 |
| Chemical Formula: | C₂₇H₂₉F₃O₆S |
| Grade: | BP/EP |
| Appearance: | White to almost white powder |
| Molar Mass: | 538.58 g/mol |
| Solubility: | Slightly soluble in water, soluble in acetone, dimethyl sulfoxide (DMSO), and methanol. |
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BroucherManufacturing process of Fluticasone furoate
The process begins with checking equipment cleanliness, utilities, and raw materials.
Charge dichloromethane to the Glass line reactor (GLR), followed by charging the steroid precursor and fluorinating reagent under controlled conditions. Heat the reaction mass up to 60–70°C and maintain the reaction mass at 60–70°C for 360–480 minutes, Take the in-process sample from reactor and send the in-porcess 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 such as hexane is added to precipitate the product.
The crystallized product is filtered through centrifugation operation and washed thoroughly with chilled solvent to remove impurities. Drying is performed in a vacuum dryer at 40–45°C for 480–600 minutes. The dried product is then milled and sieved to achieve uniform particle size.
Finally, Pack Fluticasone Furoate 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 Furoate in a tightly closed, light-resistant container at a temperature of 20°C to 25°C.
Applications of Fluticasone furoate
Technical Specifications of Fluticasone furoate
| Sr.No. | Test | Specification |
|---|---|---|
| 1 | Description | White to off-white powder |
| 2 | Solubility | Practically insoluble in water; slightly soluble in acetone and dichloromethane |
| 3 | Identification by IR | The IR spectrum of the sample should be concordant with the reference standard |
| 4 | Assay by HPLC | 97.0% to 102.0% (on anhydrous basis) |
| 5 | Related Substances by HPLC | Individual Impurity Limits: – Impurity A: Not more than 0.15% – Impurity B: Not more than 0.15% – Impurity C: Not more than 0.15% – Impurity D: Not more than 0.15% – Impurity E: Not more than 0.15% – Impurity F: Not more than 0.15% – Impurity G: Not more than 0.15% – Impurity H: Not more than 0.15% – Impurity I: Not more than 0.15% – Impurity J: Not more than 0.15% Total Impurities: Not more than 1.0% |
| 6 | Residual Solvents by GC | – Ethanol: Not more than 5000 ppm – Methanol: Not more than 3000 ppm – Dichloromethane: Not more than 600 ppm |
| 7 | Water Content | Not more than 0.5% |
| 8 | Sulfated Ash | Not more than 0.2% |
Packing and Storage condition of Fluticasone furoate
Pack Fluticasone Furoate 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 Furoate in a tightly closed, light-resistant container at a temperature of 20°C to 25°C.
Why Choose Chemignition for
Fluticasone furoate Supply?
Quality Assurance
Grade Compliance
Fluticasone furoate 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 furoate 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.
