Clinofibrate is a fibric acid derivative and lipid-lowering active pharmaceutical ingredient used for the management of disorders associated with elevated blood lipid levels. It belongs to the fibrate class of compounds and acts primarily through activation of PPAR-α, influencing lipid metabolism.
Clinofibrate is chemically identified as 2,2′-(4,4′-Cyclohexylidenediphenoxy)-2,2′-dimethylbutanoic acid. It has the molecular formula C₂₈H₃₆O₆ and molecular weight 468.58 g/mol.
| Field | Value |
|---|---|
| Product Name | Clinofibrate |
| CAS Number | 30299-08-2 |
| Alternate CAS / CAS 2 | None |
| Grade | API / Pharmaceutical Grade |
| Category | Active Pharmaceutical Ingredient |
| Appearance | White to yellowish-white powder |
| Molecular Formula | C₂₈H₃₆O₆ |
| Molecular Weight | 468.58 g/mol |
| Chemical Class | Fibric acid derivative |
| Therapeutic Class | Lipid-lowering agent |
| Pharmacological Class | Fibrate / PPAR-α agonist |
| Physical Form | Powder |
| Odour | Odourless |
| Taste | Tasteless |
| Water Solubility | Practically insoluble |
| Optical Rotation | No optical rotation |
| Standards Compliance | Japanese Pharmacopoeia |
The Japanese Pharmacopoeia describes Clinofibrate as a white to yellowish-white powder, freely soluble in methanol, ethanol, acetone and diethyl ether, and practically insoluble in water.
| Parameter | Specification |
|---|---|
| Appearance | White to off-white crystalline powder |
| Identification | UV spectrum conforms to Clinofibrate Reference Spectrum |
| Assay (HPLC) | NLT 98.5% on dried basis |
| Loss on Drying | NMT 0.5% |
| Residue on Ignition | NMT 0.1% |
| Heavy Metals | NMT 20 ppm |
| Total Impurities | NMT 1.0% |