| Name of the Product |
: |
Lansoprazole enteric coated pellets |
| INN Name |
: |
Lansoprazole |
| Chemical Name |
: |
2-(((3-Methyl-4(2,2,2-trifluoro ethoxy)-2pyridinyl) methyl)sulfiny)-IH-benzimidazole |
| Molecular formula |
: |
C16H14F3N3O2S |
| Molecular weight |
: |
369.37 |
| Packing |
: |
Black Polythene bag lined fibre board/HDPE drums |
| Description |
: |
White or pale brown-white colored enteric coated pellets |
| Identification |
: |
UV absorption
TLC
HPLCRT
|
| Water (by KF) |
: |
Not more then 1.8% w/w |
|
| Dissolution |
| Acid media |
: |
Not more than 10% of Lansoprazole is soluble after 60 minutes |
| Buffer media |
: |
Not less than 70% of Lansoprazole is soluble after 60 minutes |
|
| Chromatographic purity |
| Lansoprazole Sulphone |
: |
Not more than 0.5% as Lansoprazole |
| Any other impurity |
: |
Not more than 0.2% as Lansoprazole |
| Total impurities |
: |
Not more than 1.0% as Lansoprazole |
|
| Assay (by HPLC) |
: |
NLT 77 mg NMT 90 mg of Lansoprazole per gm Of pellets |
|
| Bulk density |
: |
0.7g to 0.9g per CC |
|
