Granisetron Hydrochloride 107007-99-8

CEP/EP; Total impurities < 0.1%, single impurity < 0.1%

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Product Details

Product Information

Product name	Granisetron Hydrochloride
CAS No.	107007-99-8
Molecular Formula	C18H21D3N4O
Molecular Weight	348.87
Quality Standard	CEP/EP; Total impurities < 0.1%, single impurity < 0.1%
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
Identification	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%	ND
	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
Microbial limits	Absence of S. aureus, E.Coli, P.aeruginosa, Salmonelia apecies	Conforms
Conclusion	Meet the EP10 specifications

Usage

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.