109889-09-0 Sell High quality Granisetron109889-09-0 factory direct supply high assay 109889-09-0
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4.Lab custom synthesis of API and intermadiates
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1. NMR,HPLC and COA can be supplied
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Items |
Specifications |
Results |
Appearance |
White or almost white powder |
Comlies |
Solubility |
Freely soluble in water, sparingly soluble in methylene chloride, slightly soluble in Methanol. |
complies |
Identification |
a) Infrared absorption spectrophtometry Comaprison: Granisetron Hydrochloride CRS b) It gives reaction (a) of chloride |
complies |
a) Solution S |
Concordant with R.S |
complies |
b) Appearance of solution |
Concordant with R.S |
complies |
c) pH |
4.0 to 6.5 |
4.6 |
d) Impurity E |
<0.5% |
complies |
Related substance |
Total <1.0% |
0.20% |
|
Impurity A ≤1.0% |
0.02% |
|
Impurity B ≤0.5% |
0.02% |
|
Impurity C ≤0.2% |
0.02% |
|
Impurity D ≤0.1% |
0.02% |
|
Any other impurity≤0.1% |
0.02% |
|
Total ≤1.0% |
0.01% |
Heavy metal |
≤10ppm |
<10ppm |
Sulphated ash |
<0.1% |
0.06% |
Loss on drying |
<0.5% |
<0.1% |
Residual Solvents |
methanol<0.3% |
0.01% |
Bacterialendotoxins |
<0.05EU/mg |
<0.05EU/mg |
Assay |
97%~102% |
100.60% |
Conclusion |
The results comply with the requirement of the EP7 |
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