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10 Gram |
Negotiable |
Ramosetron Hydrochloride RAMOSETRON HYDROCHLORIDE Ramosetron hcl
≥98.5%
Characteristics |
White or yellowish crystalline powder with hygroscopicity |
|
Easily dissoluted in water or methanol,slightly dissoluted in alcohol or glacial acetic acid,poorly dissoluted in acetonitrile tetrahydrofuran or ether |
|
Specific rotation -41.5°~-44.5° |
Identification |
The UV spectrum exhibits the maximum absorption at 248nm or 311nm |
|
In accordance with the reference standard spectrum of Ramosetron hydrochloride |
|
Produce chlorides in the reaction of identification |
Acidity |
PH value 4.0~5.0 |
Color and clarity |
The solution should be clear,if the color is produced ,it should be not darker than that of the standard preparation (NO.2 yellow tube) |
Related impurities |
≤1.0% |
Methanol and acetic ether |
Methanol ≤0.3% Acetic ether ≤0.5% |
Acetonitrile |
≤0.041% |
Optical isomer |
≤0.4% |
Water |
≤0.5% |
Residue on ignition |
≤0.1% |
Heavy metals |
≤0.001% |
Microbial limits |
Total microbial count ≤1000cfu/g Mould and yeast fungus ≤100cfu/g |
Assay |
C17H17N3O HCL ≥98.5% (calculated on the anhydrous basis) |
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