Key Properties of Latanoprostene Bunod
| Product Name: | Latanoprostene Bunod |
| Synonyms: | 4-Nitrooxybutyl (Z)-7-[(1R,2R,3R,5S)-3,5-dihydroxy-2-[(3R)-3-hydroxy-5-phenylpentyl]cyclopentyl]hept-5-enoate |
| CAS No: | 919007-12-9 |
| Chemical Formula: | C₂₇H₄₁NO₈ |
| Grade: | USP/IP/IH |
| Appearance: | Colorless to yellow oil |
| Molar Mass: | 616.69 g/mol |
| Solubility: | Insoluble in water, but its soluble in organic solvents such as ethanol and methanol |
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BroucherManufacturing process of Latanoprostene Bunod
Before starting the process operation, ensure the cleanliness of equipment, confirm the availability of utilities, and verify the availability of raw materials and packing materials.
Charge suitable solvent (e.g., ethanol) into the glass pot and charging the Latanoprostene intermediate and a nitric oxide donor under controlled stirring. Stir the reaction mass for 10-15 minutes and maintain the reaction mass at 20–30°C for 360–480 minutes, Take in-process sample from reaction mass and send the in-process sample to QC for reaction monitoring by HPLC.
After the reaction, the product is extracted using a solvent system for purification. The crystallization process is initiated by cooling the mixture to 5–10°C and adding an anti-solvent. The mixture is stirred for 120–180 minutes, and the solid product is filtered using vacuum filtration. The product is then washed with chilled solvent to remove impurities. Drying is performed in a vacuum dryer at -10°C to -20°C for 480–600 minutes.
Pack Latanoprostene Bunod 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 Latanoprostene Bunod in a tightly closed, light-resistant container at a temperature of -20°C to -10°C.
Applications of Latanoprostene Bunod
Technical Specifications of Latanoprostene Bunod
| Sr.No. | Test | Specification |
|---|---|---|
| 01 | Description | Pale yellow to yellow colored oil |
| 02 | Solubility | Freely soluble in methanol |
| 03 | Identification | A) By IR: Infrared absorption spectrum obtained from the sample should correspond to the Latanoprostene Bunod reference standard spectrum. |
| 04 | Water Content | Not more than 1.50% |
| 05 | Specific Optical Rotation | +25° to +30° |
| 06 | Related Substances by HPLC | A) Latanoprostene Bunod TPPO Impurity: Not more than 0.15% B) Latanoprostene Bunod Acid Impurity: Not more than 0.15% C) 15S Latanoprostene Bunod Impurity: Not more than 0.50% D) 5,6 Trans Latanoprostene Bunod Impurity: Not more than 0.50% E) Individual Unspecified Impurity: Not more than 0.15% F) Total Impurity: Not more than 1.00% |
| 07 | Assay by HPLC (on anhydrous basis) | Not less than 94.0% w/w to not more than 102.0% w/w |
| 08 | Residual Solvents by GC | A) Methanol: Not more than 3000 ppm B) Acetone: Not more than 5000 ppm C) MTBE: Not more than 5000 ppm D) THF: Not more than 720 ppm E) Ethanol: Not more than 5000 ppm F) Dichloromethane: Not more than 600 ppm |
Packing and Storage condition of Latanoprostene Bunod
Pack Latanoprostene Bunod 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 Latanoprostene Bunod in a tightly closed, light-resistant container at a temperature of -20°C to -10°C.
Why Choose Chemignition for
Latanoprostene Bunod Supply?
Quality Assurance
Grade Compliance
Latanoprostene Bunod 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
Latanoprostene Bunod 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.
