| Synonyms |
2-[[[3-Methyl-4-(2,2,2-trifluoro ethoxy) -2-pyridinyl]-methyl]-sulfinyl]-1H Benzimidazole |
| |
1H Benzimidazole, 2-[[[3- Methyl- 4-(2,2,2-trifluoro ethoxy)-2-pyridinyl]- methyl]-sulfinyl] |
Molecular Formula
|
C16H14N3F3SO2 |
| Molecular Weight |
369.37 |
| CAS Number |
103577-45-3 |
| S. No. |
Test |
Specification |
| 1 |
Description |
A White to off white crystalline powder |
| 2 |
Solubility |
Soluble in Methanol, Sparingly soluble in 0.1 N Sodium Hydroxide solution. Slightly soluble in Chloroform and Acetone |
| 3 |
Identification |
|
|
A) Ultra Violet
Absorption |
The U.V spectrum of a 0.001% w/v solution in methanol and in 0.1N NaoH exhibits maxima at about 285nm and 292 nm respectively when scanned between 230nm to 350 nm. In methanol at 285nm. |
| B) Infra Red Absorption |
The infrared absorption spectrum of a Potassium Bromide dispersion of it exhibits maxima at the same wavelengths as that of a similar preparation of Lansoprazole CRS |
| 4 |
Water Content by K.F. |
Not more than 0.1% |
| 5 |
Sulphated Ash |
Not more than 0.1% |
| 6 |
Chromatographic Impurity by HPLC |
|
| a) Related compound – A |
Not more than 0.4% |
| b) Impurity – B |
Not more than 0.1% |
| c) Impurity – C |
Not more than 0.1% |
| d) Other individual Impurity |
Not more than 0.1% |
|
e) Total Impurity |
Not more than 0.6% |
| 7 |
Assay by HPLC |
Lansoprazole contains Not less than 99.0% and Not more than 101.0%on dried substances. |
