Ezetimibe IP/USP is a pharmaceutical ingredient recognized for its cholesterol-lowering properties, helping to reduce the absorption of cholesterol from the diet and promoting heart health.
| Specification | Value |
|---|---|
| Identification | Conforms to IP/USP |
| Appearance | White or off-white powder |
| Melting point | 163-164°C |
| Loss on drying | Not more than 0.5% |
| Heavy metals | Not more than 20 ppm |
| Residue on ignition | Not more than 0.1% |
| Assay | 98.0% – 102.0% |
| Related substances | Not more than 1.0% of any impurity |
| Microbial limits | Complies with specified criteria |
| Particle size distribution | 90% of particles between 10-50 microns |
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