 |
 |
|
|
|
| Milen Omeprazole |
 |
| Omeprazole |
 |
| 73590-58-8 |
 |
| Pharmaceutical |
 |
Description : A white or almost white powder
Solubility : Very slightly soluble in water, soluble in alcohol, in methanol, in methylene chloride.
Identification ( A ) : Examined between 230 nm and 350 nm, The ratio of the absorbance measured at max. 305 nm to that measured at max. 276 nm, is 1,6 to 1,8.
Identification ( B ) : Examine by infrared absorption spectrum, comparing with the reference standard spectrum.
Identification ( C ) : The principal spot of sample must be similar with the reference standard.
Appearance of Solution : Solution S is clear.
Absorbance : Not more than 0,10 at 440 nm
Omeprazole Impurity C : Max. 0,1 %
Related Substances: Individual Impurity : Max. 0,1 %, Total Impurities : Max. 1,0 %
Residual Solvents: Chloroform : Max. 50 ppm, Methylene Chloride : Max. 100 ppm, Ethyl Acetate : Max. 1000 ppm
Loss on Drying : Max. 0,2 %
Sulphated Ash : Max. 0,1 %
Assay : 99,0 - 101,0 % |
|
|
|
|
|
