Pragna Group offers cGMP-compliant Nebivolol API manufactured to the highest quality standards. Nebivolol API is a highly selective third-generation beta-blocker with unique vasodilatory properties. This medication offers a range of benefits for treating cardiovascular conditions, including hypertension, angina pectoris, and heart failure. Nebivolol API belongs to the class of beta-blockers, which work by blocking the action of the hormone adrenaline on beta-adrenergic receptors in the heart and blood vessels. provide competitive prices for bulk quantities of Nebivolol API.
| Sr. No | Test | Specification | |
|---|---|---|---|
| 1 | Description | White to off white powder. | |
| 2 | Solubility | Sparingly soluble in Methanol. | |
| 3 | Identification (A) By IR | A) The infrared absorption spectrum of the substance being examined in potassium bromide disc should be concordant with the spectrum obtained from Nebivolol HCL standard. | |
| (B) By HPLC | B) Retention time of the sample should match with that of working standard. | ||
| 4 | Loss on drying | Not more than 0.5% w/w | |
| 5 | Specific optical rotation | Between -1.00 and +1.00 | |
| 6 | Sulphated ash | Not more than 0.1% w/w | |
| 7 | Heavy metals | Not more than 10 ppm | |
| 8 | Related substances by HPLC: | ||
| A. Nebivolol Isomer at about 0.88 RRT | Not more than 0.10% | ||
| B. Nebivolol Isomer at about 1.13 RRT | Not more than 0.10% | ||
| C. Highest individual impurity | Not more than 0.10% | ||
| D. Total impurities | Not more than 1.0% | ||
| 9 | Chromatographic Chiral purity | 1. D-isomer between 48.5% and 51.5%. | |
| (By % area) | 2. L-isomers between 48.5% and 51.5% | ||
| 3. Total of DL-isomers: Not less than 99.0% | |||
| 10 | Assay (By Potentiometry) | Between 98.5% and 101.5% w/w on dried basis. | |
| 11 | Residual Solvents | ||
| (a) Methanol | Not more than 1000 ppm | ||
| (b) IPA | Not more than 1000 ppm | ||
