WITH QUALITY CREATING FUTURE
WITH QUALITY CREATING FUTURE
Lansoprazole is a proton-pump inhibitor (PPI) which inhibits the stomach's production of gastric acids.Lansoprazole is manufactured by a number of companies worldwide under several brand names. Lansoprazole is a proton-pump inhibitor (PPI) in the same pharmacologic class as omeprazole.Lansoprazole has been marketed for many years and is one of several PPIs available.Lansoprazole is a racemate 1:1-mixture of the enantiomers dexlansoprazole and levolansoprazole.
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Test Item |
Analysis Specification |
Result |
|
Description |
White to off white crystalline powder |
Conforms |
|
Melting range |
129°C~132°C |
130.8°C-131°C |
|
Loss on drying |
≤0.5% |
0.20 % |
|
Specific rotation |
-58°~-62°(C=1,in CH3OH) |
-61.05° |
|
Sulphated ash |
≤0.1% |
0.08 % |
|
Heavy metals |
≤10ppm |
Conforms |
|
Chlorides |
≤0.02% |
Conforms |
|
Sulfates |
≤0.02% |
Conforms |
|
Fluorine |
14.7%~17.9% |
15.2% |
|
Residual solvent |
Methanol ≤0.2% Isopropanol ≤0.2% Ethyl acetate≤0.2% Chloroform ≤0.2% |
0.0% 0.0% 0.0% 0.0% |
|
Related substances (HPLC) |
Single impurity ≤0.2% Total impurities ≤0.5% |
0.05% 0.08% |
|
Assay |
≥99.5% |
99.92% |
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Conclusion |
Accordance with the reference |
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