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100 Gram |
FOB Price: USD 10.0000 |
Granisetron hcl Granisetron 99% Granisetron hcl
Why is SINOWAY:
1) Specialized in pharmaceutical and healthcare industrial for 34 years.
2) ISO 9001:2015 & SGS audited supplier .
3) Accept various payment terms : T.T 30-60 days.
4) We have warehouse in USA with quickly shipment .
5) We can do different terms of FOB ,CIF/CIP ,DDP ...
1. Company Profile:
SINOWAY INDUSTRIAL CO.,LTD is a state-owned company and a professional supplier in exporting
Pharmaceutical Raw and its intermediates, Cosmetic Raw Material, Healthcare Product from China
since 1987, about 34 years experiences to Europe, America and Southeast Asia. We have gained very
good reputation from all our customers in the world.
Custom manuafacturing is very strong from us.We have developed some new items together with
our local universityand institute special for our oversea clients for long term business under signing secret
agreement.
2. Quality information for Granisetron hcl
USP Current
Items | Specifications | Results |
Appearance | White or almost white powder | Conforms |
Identification | ||
A: IR Spectrum | A: Sample IR spectrum comparable with that of the standard | Conforms |
B: Chloride | B: Positive | Conforms |
pH | 4.0~6.5 | 5.92 |
Impurity E (by TLC) | NMT0.5% | <0.5% |
Loss on drying | NMT0.5% | 0.03% |
Heavy Metals | NMT20ppm | <20ppm |
Related Compounds | Impurity A: NMT1.0% | ND |
Impurity B: NMT0.5% | ND | |
Impurity C: NMT0.2% | 0.04% | |
Impurity D: NMT0.1% | ND | |
Any other impurity : NMT1.0% | 0.03% | |
Total impurity: NMT1.0% | 0.07% | |
Residual Solvents | ||
Ethanol | NMT 1000ppm | 314ppm |
Isopropanol | NMT 1000ppm | 13ppm |
DIchloromethane | NMT 300ppm | 2ppm |
Assay by HPLC | 97.0%~102.0% | 100.10% |
Conclusion | The product meets USP Specifications |
EP
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 |
3. Use for Granisetron hcl
1) Granisetron Hydrochloride is a highly s elective 5-HT 3 receptors inhibitor. It is favourable
effective for the prevention and the treatment of nausea and vomiting caused by actinotheraphy,
chemotherapy or surgical.
2) These factor cause intestine chromaffin cell to release of 5-HT which activation 5-HT 3 receptors
of nerve centre or vagus and hence resulting from reflection of vomit.
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