Key Properties of Latanoprost
| Product Name: | Latanoprost |
| Synonyms: | Isopropyl (Z)-7-[(1R,2R,3R,5S)-3,5-dihydroxy-2-[(3R)-3-hydroxy-5-phenylpentyl]cyclopentyl]hept-5-enoate |
| CAS No: | 130209-82-4 |
| Chemical Formula: | C₂₆H₄₀O₅ |
| Grade: | USP/IP/IH |
| Appearance: | Colorless to slightly yellow oil |
| Molar Mass: | 432.58 g/mol |
| Solubility: | Insoluble in water, but it is soluble in organic solvents such as ethanol and methanol. |
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BroucherManufacturing process of Latanoprost
Before starting the process operation, ensure the cleanliness of all equipment, verify that all utilities are available, and confirm the availability of raw materials and packing materials.
Charge acetonitrile to the glass pot and charge the Latanoprost intermediates and reagents under stirring. Stir the reaction mass for 10-15 minutes. Maintain the reaction mass at 25–30°C for 360–480 minutes,
Take in-process sample from reaction mass and send in-process sample to Quality control (QC) for reaction monitoring by HPLC. After the reaction, the product is purified by extracting it with an appropriate solvent system. Crystallization is initiated by adding an anti-solvent to the product mixture and cooling it to 5–10°C. The product is filtered and washed with chilled solvent to remove impurities. The product is then dried under vacuum at -10°C to -20°C.
Pack Latanoprost in a glass or polypropylene (PP) 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 Latanoprost in a tightly closed, light-resistant container at a temperature of -20°C to -10°C.
Applications of Latanoprost
Technical Specifications of Latanoprost
| Sr.No. | Test | Specification |
|---|---|---|
| 01 | Description | A colourless to yellowish oil |
| 02 | Solubility | Freely soluble in methanol |
| 03 | Identification | A) By IR: Infrared absorption spectrum obtained from the sample should correspond to the Latanoprost reference standard spectrum. B) 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. |
| 04 | Water Content | Not more than 2.0% |
| 05 | Specific Optical Rotation | +31° to +38° |
| 06 | Related Substances by HPLC | A) Latanoprost Impurity E: Not more than 0.20% B) Isopropyl Diphenylphosphorylpentanoate: Not more than 0.10% C) Latanoprost Impurity B: Not more than 0.50% D) Latanoprost Impurity A: Not more than 3.50% E) Any Individual Impurity: Not more than 0.10% F) Total Impurity (excluding Impurities A & B): Not more than 0.50% |
| 07 | Assay by HPLC (on anhydrous basis) | Not less than 96.0% w/w to not more than 102.0% w/w |
| 08 | Residual Solvent by GC | A) Dichloromethane: Not more than 600 ppm B) Ethyl Acetate: Not more than 5000 ppm C) Acetone: Not more than 5000 ppm |
Packing and Storage condition of Latanoprost
Pack Latanoprost in a glass or polypropylene (PP) 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 Latanoprost in a tightly closed, light-resistant container at a temperature of -20°C to -10°C.
Why Choose Chemignition for
Latanoprost Supply?
Quality Assurance
Grade Compliance
Latanoprost 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
Latanoprost 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.
