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Lafutidine (INN) is a second generation histamine H2 receptor antagonist having multimodal mechanism of action and used to treat gastrointestinal disorders.
Lafutidine is used to treat gastric ulcers, duodenal ulcers, as well as wounds in the lining of the stomach associated with acute gastritis and acute exacerbation of chronic gastritis.
Specification:
|
Items |
Standards |
|
Appearance |
White or almost white powder |
|
Identification |
Corresponds |
|
Melting point |
96-100°C |
|
Identification |
HPLC |
|
UV |
|
|
Related substances |
Total impurities:NMT1.0% Maximum single impurity:NMT0.5% |
|
Assay(on dried basis) |
NLT99.0% |
|
Residue on ignition |
NMT0.1% |
|
Heavy metal |
NMT20ppm |
|
Loss on drying |
≤1.0% |
Packaging details:
|
Packaging details: |
25kg/drum with double plastic bags inside; packed in a cardboard drum or fiber HDPE drum. |
|
Storage: |
Stored in a clean, cool, dry area; keep away from moisture and strong, direct light/heat |
|
Shelf Life: |
5 years if sealed and store away from direct sun light. |
