Key Properties of Misoprostol 1% HPMC
| Product Name: | Misoprostol 1% HPMC |
| Synonyms: | Methyl 7-[(1R,2R,3R)-3-hydroxy-2-[(E)-4-hydroxy-4-methyloct-1-enyl]-5-oxocyclopentyl]heptanoate |
| CAS No: | 59122-46-2 |
| Chemical Formula: | C₂₂H₃₈O₅ |
| Grade: | IH |
| Appearance: | Clear or slightly cloudy liquid. |
| Molar Mass: | 382.55 g/mol |
| Solubility: | Insoluble in water but is soluble in organic solvents like ethanol |
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BroucherManufacturing process of Misoprostol 1% HPMC
Before starting the process operation, check the cleanliness of equipment, ensure the availability of utilities, and verify the availability of raw materials and packing materials.
The preparation of the HPMC base involves dissolving hydroxypropyl methylcellulose (HPMC) in water under stirring, maintaining a temperature of 50–60°C until fully dissolved. Misoprostol is then added to the HPMC solution under constant stirring, ensuring the temperature is maintained at 25–30°C to prevent degradation.
The mixture is homogenized using a high-shear mixer to ensure uniform dispersion. The solution is filtered to remove any particulate matter.
Pack Misoprostol 1% HPMC 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 Misoprostol 1% HPMC in a tightly closed, light-resistant container at a temperature of 20°C to 25°C.
Applications of Misoprostol 1% HPMC
Technical Specifications of Misoprostol 1% HPMC
| Sr.No. | Test | Specification |
|---|---|---|
| 1 | Appearance | White to off-white powder |
| 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 (Misoprostol content) | 0.90% to 1.10% w/w |
| 4 | Water Content | Not more than 5.0% |
| 5 | Related Substances (by HPLC) | Individual impurity: Not more than 0.15% Total impurities: Not more than 0.5% |
| 6 | Heavy Metals | Not more than 20 ppm |
| 7 | Particle Size | 100% passing through a 60-mesh sieve |
| 8 | Residual Solvents | 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 Misoprostol 1% HPMC
Pack Misoprostol 1% HPMC 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 Misoprostol 1% HPMC in a tightly closed, light-resistant container at a temperature of 20°C to 25°C.
MSDS - Misoprostol 1% HPMC
Why Choose Chemignition for
Misoprostol 1% HPMC Supply?
Quality Assurance
Grade Compliance
Misoprostol 1% HPMC 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
Misoprostol 1% HPMC 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.
