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Granisetron Hydrochloride 107007-99-8

Granisetron Hydrochloride 107007-99-8

97% up by HPLC
  • Product Details

Product Information


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 watersparingly 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


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.

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If you are interested in our products and want to know more details,please leave a message here,we will reply you as soon as we can.

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