Product name | Granisetron Hydrochloride |
CAS No. | 107007-99-8 |
Molecular Formula | C18H21D3N4O |
Molecular Weight | 348.87 |
Quality Standard | 97% up by HPLC |
Appearance | White powder |
COA of Granisetron Hydrochloride |
Items | Specifications | Results |
Appearance | White or almost white powder | White powder |
Identification | IR spectrum: Simple IR spectrum comparable with that of the standard | Conforms |
Chloride: Positive | Conforms |
Solubility | Freely soluble in water，sparingly soluble in methanol very slightly soluble in methylene chloride. | Conforms |
Appearance of solution | Clear and colourless | Conforms |
pH | 4.0-6.5 | 5.88 |
Impurity E(by TLC) | NMT 0.5% | < 0.5% |
Loss on drying | NMT 0.5% | 0.05% |
Sulphated ash | NMT 0.1% | 0.02% |
Related substances | 2-methyl-N-[(1R,3r,5S)-9-methyl-9-azabicyclo[3.3.1]non-3- yl]-2H-indazole-3 carboxamide (Impurity A): NMT 1.0% | ND |
N-[(1R,3r,5S)-9-methyI-9-azabicyclo[3.3.1]non-3-yI]-1H-in dazole-3 carboxamide (Impurity B): NMT 0.5% | ND |
N-[(1R,3r,5S)-9-azabicyclo[3.3.1]non-3-yl]-1-methyl-1H-in dazole-3 carboxamide ( Impurity C):NMT 0.2% | 0.01% |
1-methyI- 1H-indazole-3- carboxylic acid ( Impurity D) : NMT0.1% | ND |
Any other impurity: NMT 0.10% | 99.26% |
Total impurities: NMT 1.0% | 0.01% |
Residual solvents | Ethanol: NMT 1000ppm | 280ppm |
Isopropanol: NMT1000ppm | ND |
Dichloromethane | ND |
Assay by HPLC | 97.0%-102.0% (dried basis) | 100.0% |
Endotoxins | NMT 125 EU/mg | < 125 EU/m |
Microbial limits | Total aerobic microbial count: NMT 100CFU/g | Conforms |
Absence of S. aureus, E.Coli, P.aeruginosa, Salmonelia apecies | Conforms |
Conclusion | Meet the EP9.0 specifications
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Function of Granisetron Hydrochloride
Granisetron hydrochloride is an antiemetic drug, mainly suitable for nausea and vomiting caused by radiotherapy, cytotoxic drug chemotherapy, and surgery. It has a better preventive and therapeutic effect. The mechanism of controlling nausea and vomiting is mainly through antagonism Central chemoreceptors and related receptors of neurotransmitters in the peripheral nervous system can inhibit the occurrence of nausea and vomiting. The selectivity of drug treatment is relatively high, and the adverse reactions to the central nervous system are relatively few. Less cause excessive sedation and other adverse reactions.
Granisetron hydrochloride is also used for surgical prevention. Generally, it only needs to be administered once. The preventive effect on nausea and vomiting can be more than 24 hours, so the effect time is relatively long. When using it, you need to pay attention to the gastrointestinal tract. Patients with obstruction are contraindicated.
