| Product Name | NEBIVOLOL HYDROCHLORIDE |
| IUPAC Name | 1-(6-fluoro-3,4-dihydro-2H-chromen-2-yl)-2-[[2-(6-fluoro-3,4-dihydro-2H-chromen-2-yl)-2-hydroxyethyl]amino]ethanol OR α-α-[{(Iminobis(methylene)-bis-[6-fluoro-3 , 4-dihydro-2H-1-benzopyran-2-methanol] hydrochloride |
| C.A.S. No | 99200-09-6 |
| Molecular Formula | C22H26O4NClF2 |
| Formula Weight | 441.9 |
| Therapeutic category | Antihypertensive |
SR. NO. |
TEST
|
SPECIFICATION
|
1 |
Description |
White to off white powder |
2 |
Identification By IR |
IR spectrum should be correspond to structure and standard. |
3 |
Solubility |
Sparingly soluble in Dimethyl formamide, Slightly |
4 |
Water |
Not more than 1.0 % w/w |
5 |
Sulphated ash |
Not more than 0.2 % |
6 |
Heavy metals |
Not more than 20 ppm. |
7 |
Related substancesHighest individual impurity Total impurities |
Not more than 0.5 % Not more than 1.0 % |
8 |
Assay(By HPLC, on anhydrous basis) |
Between 98.0 % and 102.0 %w/w |
9 |
Additional test
(2). Residual solvents
|
(a) D - Isomer between 48 % and 52 %
(a) Not more than 3000 ppm |
