109889-09-0 Granisetron granisetron hydrochloride
Granisetron is a serotonin 5-HT3 receptor antagonist used as an antiemetic to treat nausea and vomiting followingchemotherapy. Its main effect is to reduce the activity of the vagus nerve, which is a nerve that activates the vomiting center in the medulla oblongata. It does not have much effect on vomiting due to motion sickness. This drug does not have any effect on dopamine receptors or muscarinic receptors.
Granisetron was developed by chemists working at the British drug company Beecham around 1988 and is available as a generic. It is produced by Roche Laboratories under the trade name Kytril. The drug was approved in the United Kingdomin 1991 and in United States in 1994 by the FDA.
A granisetron transdermal patch with the trade name Sancuso was approved by the US FDA on September 12, 2008.[1] Sancuso is manufactured by ProStrakan, Inc., a pharmaceutical company headquartered in Bedminster, NJ, with global headquarters in Scotland.
Granisetron is metabolized slowly by the liver, giving it a longer than average half-life. One dose usually lasts 4 to 9 hours and is usually administered once or twice daily. This drug is removed from the body by the liver and kidneys.
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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