Key Properties of Tafluprost
| Product Name: | Tafluprost |
| Synonyms: | Isopropyl (5Z)-7-{(1R,2R,3R,5S)-2-[(1E)-3,3-difluoro-4-phenoxybut-1-en-1-yl]-3,5-dihydroxycyclopentyl}hept-5-enoate |
| CAS No: | 209860-87-7 |
| Chemical Formula: | C₂₅H₃₄F₂O₅ |
| Grade: | USP/IP/IH |
| Appearance: | Colorless to pale yellow liquid. |
| Molar Mass: | 452.6 g/mol |
| Solubility: | Insoluble in water but soluble in organic solvents such as ethanol and acetonitrile. |
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BroucherManufacturing process of Tafluprost
Before starting the operation, ensure the cleanliness of equipment, availability of utilities, and confirmation of raw materials and packing materials.
Charge dichloromethane in glass pot and add prostaglandin derivatives and reagents for esterification. The reaction is maintained at 25–30°C for 360–480 minutes. After the reaction, the mixture is cooled to 0–5°C, and an anti-solvent is added to initiate crystallization.
The product is then filtered and washed with chilled anti-solvent. The final product is dried under vacuum at -20°C. Pack Tafluprost in a glass or polypropylene vial. Place the vial inside a poly bag, twist its mouth, and secure it with a PVC strip. Insert this bag into a triple-laminated aluminum bag and seal it properly. Finally, place the sealed aluminum bag in an HDPE container. Store Tafluprost in a tightly closed, light-resistant container at a temperature of -20°C to -10°C.
Applications of Tafluprost
Technical Specifications of Tafluprost
| Sr.No. | Test | Specification |
|---|---|---|
| 01 | Description | Light yellow viscous oil |
| 02 | Solubility | Freely soluble in ethanol |
| 03 | Identification | A) By HPLC: The retention time of the principal peak in the chromatogram of the sample preparation should match with that of the standard preparation as obtained in the assay test. B) By IR: Infrared absorption spectrum obtained from the sample should correspond to the Tafluprost reference standard spectrum. |
| 04 | Water Content | Not more than 0.5% |
| 05 | Specific Optical Rotation | +16° to +23° |
| 06 | Related Substances by HPLC | Purity: Not less than 99.0% Tafluprost related 5,6 trans: Not more than 0.15% Tafluprost related Acid: Not more than 0.15% Tafluprost related TPP: Not more than 0.15% Any other individual impurity: Not more than 0.10% Total impurity: Not more than 0.50% |
| 07 | Assay by HPLC (on anhydrous basis) | Not less than 98.0% w/w to not more than 102.0% w/w |
| 08 | Residual Solvents by GC | Dichloromethane: Not more than 600 ppm Methyl tert-butyl ether: Not more than 5000 ppm Ethyl acetate: Not more than 5000 ppm THF: Not more than 720 ppm Methanol: Not more than 3000 ppm Ethanol: Not more than 5000 ppm Acetone: Not more than 5000 ppm Acetonitrile: Not more than 410 ppm |
Packing and Storage condition of Tafluprost
Pack Tafluprost in a glass or polypropylene vial. Place the vial inside a poly bag, twist its mouth, and secure it with a PVC strip. Insert this bag into a triple-laminated aluminum bag and seal it properly. Finally, place the sealed aluminum bag in an HDPE container. Store Tafluprost in a tightly closed, light-resistant container at a temperature of -20°C to -10°C.
Why Choose Chemignition for
Tafluprost Supply?
Quality Assurance
Grade Compliance
Tafluprost 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
Tafluprost 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.
