97% up by HPLC Granisetron Hydrochloride 107007-99-8

Category:Active Pharmaceutical Ingredients > Other Active Pharmaceutical Ingredients
Product Name:97% up by HPLC Granisetron Hydrochloride 107007-99-8
CAS No.:107007-99-8
Standard:USP, BP, EP, JP, In-house Standards
Price(USD):Negotiable
Company:Sinoway Industrial Co.Ltd.

Basic Info
  • Grade: Pharmaceutical Grade

    Factory Location: Xiamen, Fujian

    Main Sales Markets: North America,Central/South America,Western Europe,Eastern Europe,Australasia,Asia,Middle East

  • Monthly Production Capacity: 1000kg

    Packaging Information: 25kg/drum 1kg/bottle

  • Delivery Lead Time: 7 days after payment

    Sample Provided: yes

    Payment Terms: L/L

    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 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

     

    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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