Tamsulosin hydrochloride Tamsulosin HCl 106463-17-6
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Identification |
(1) Should conformed (2) Specific rotation: between -17.5 and -20.5° (3) Examine by infrared absorption spectrophotometry, compare the spectrum obtained with reference spectrum: should meet the requirement. (4) Should conformed |
(1) Conformed (2) -18.2° (3) Conformed
(4) Conformed |
Optical rotation |
-0.10°~+0.10° |
+0.00° |
Water |
≤0.5% |
0.03% |
Sulphated ash |
≤0.2% |
0.04% |
Related substances |
Method A (EP method): Largest single impurity should ≤0.1% Method B (EP method): Largest single impurity should ≤0.1% Total impurities should ≤0.2% |
0.007%
0.09% 0.01% |
Enantiomeric purity |
Not more than 0.1% |
0.04% |
Heavy metals |
Not more than 20 ppm |
Conformed |
Loss on drying |
Not more than 0.5% |
0.09% |
Sulphated ash |
Not more than 0.1% |
0.08% |
Assay |
Should between 98.5 and 101.0 per sent |
99.4% |
EP standard
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