Key Properties of Mometasone Furoate
| Product Name: | Mometasone Furoate |
| Synonyms: | 9α,21-Dichloro-11β-hydroxy-16α-methyl-3,20-dioxopregna-1,4-dien-17-yl furan-2-carboxylate |
| CAS No: | 83919-23-7 |
| Chemical Formula: | C27H30Cl2O6 |
| Grade: | BP/USP |
| Appearance: | Crystalline powder |
| Molar Mass: | 521.44 g/mol |
| Solubility: | Practically insoluble in water; freely soluble in acetone, ethanol, and methanol |
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BroucherManufacturing process of Mometasone Furoate
Before starting the process operation, ensure the cleanliness of all equipment and verify that all necessary utilities, raw materials, and packing materials are available.
Charge Acetone in to glass line reactor (GLR) and charge starting intermediate and reagents for esterification. Heat the reaction mass up to 50–60°C and maintain the reaction mass temperature at 50–60°C for 360–480 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 5–10°C, and an anti-solvent is added to initiate crystallization.
The product is filtered and washed with chilled anti-solvent. The wet cake is then dried in a vacuum dryer at 50–60°C for 360–480 minutes.
Pack Mometasone 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 Mometasone furoate in a tightly closed, light-resistant container at a temperature below 30°C.
Applications of Mometasone Furoate
Technical Specifications of Mometasone Furoate
1DescriptionWhite to off-white crystalline powder
| Sr.No. | Test | Specification |
|---|---|---|
| 2 | Identification | A) Infrared (IR) spectroscopy: The IR spectrum of the sample should match that of the reference standard. B) High-Performance Liquid Chromatography (HPLC): The retention time of the principal peak in the sample solution should correspond to that of the standard solution. |
| 3 | Assay (Content of Mometasone Furoate) | 97.0% to 102.0% (on dried basis) |
| 4 | Loss on Drying | Not more than 0.5% |
| 5 | Residue on Ignition | Not more than 0.1% |
| 6 | Heavy Metals | Not more than 20 ppm |
| 7 | Related Substances (by HPLC) | Impurity A: Not more than 0.3% Impurity B: Not more than 0.1% Impurity C: Not more than 0.1% Impurity D: Not more than 0.1% Unspecified Individual Impurity: Not more than 0.5% Total Impurities: Not more than 2.0% |
| 8 | Residual Solvents (by Gas Chromatography) | Methanol: Not more than 3000 ppm Ethanol: Not more than 5000 ppm Dichloromethane: Not more than 600 ppm Acetone: Not more than 5000 ppm |
Packing and Storage condition of Mometasone Furoate
Pack Mometasone 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 Mometasone furoate in a tightly closed, light-resistant container at a temperature below 30°C.
Why Choose Chemignition for
Mometasone Furoate Supply?
Quality Assurance
Grade Compliance
Mometasone 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
Mometasone 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.
