Fimasartan is an angiotensin II receptor blocker (ARB) and active pharmaceutical ingredient used in the development and manufacture of antihypertensive pharmaceutical formulations. It selectively targets the angiotensin II type 1 (AT1) receptor and is associated with inhibition of angiotensin II-mediated vasoconstrictive activity.
Fimasartan has the molecular formula C27H31N7OS and a molecular weight of approximately 501.65 g/mol. Its CAS Number is 247257-48-3.
Fimasartan API is available as a solid/powder material. Commercial analytical material is reported as white to beige powder, while published supplier information reports high-purity Fimasartan tested by HPLC.
Fimasartan is primarily associated with pharmaceutical formulations for the management of hypertension. It belongs to the angiotensin II receptor antagonist/ARB class.
Fimasartan API quality is evaluated using analytical techniques such as IR and HPLC for identification and assay. Specific acceptance criteria for impurities, water content, residual solvents and other quality attributes should be established according to the applicable approved specification and batch documentation.
Note: Product specifications, assay limits, impurity limits, residual solvents and other release criteria should always be confirmed against the current Certificate of Analysis (CoA) and approved manufacturer specification.
| Parameter | Specification |
|---|---|
| Appearance | White to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.0% – 102.0% |
| Loss on Drying | NMT 1.0% |
| Residue on Ignition | NMT 0.5% |
| Heavy Metals | NMT 20 ppm |
| pH (1% Solution) | 2.0 – 4.0 |
| Individual Impurity | NMT 0.5% |
| Total Impurities | NMT 1.0% |
| Water Content | NMT 1.0% |