Product Brief Introduction
Product name: Tropisetron Hydrochloride
CAS: 105826-92-4
MF: C17H21ClN2O2
MW: 320.82
Product Specification
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Appearance |
White or off-white powder |
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Odor |
Odorless |
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Identification |
IR: the infrared absorption spectrum of the sample complies with the reference standard. |
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HPLC: the retention time of the major peak of the sample solution corresponds to that of the standard solution, as obtained in the assay. |
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Reaction (a)of chloride: It gives positive reaction |
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Solubility |
Meets the standards |
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Appearance of Solution |
The solution is clear and not more intensely coloured than reference solution B7 |
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PH |
5.0-6.5 |
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Loss on Drying |
≤ 0.3% |
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Residue on Ignition |
≤ 0.1% |
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Related Substances |
Impurity A ≤ 0.5% |
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Impurity I ≤ 0.1% |
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Impurity V ≤ 0.1% |
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Impurity VI ≤ 0.1% |
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Impurity VII ≤ 0.1% |
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Impurity II ≤ 0.03% |
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Unspecified impurity ≤ 0.1% |
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Total impurities ≤ 0.3% |
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Alpha-Tropinol Impurity III ≤ 0.2% |
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Beta-Isomer Impurity IV ≤ 0.1% |
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Heavy Metals |
≤ 10ppm |
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Residual Solvents |
Methanol ≤ 3000ppm |
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Dichloromethane ≤ 600ppm |
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Tetrahydrofuran ≤ 720ppm |
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Ethyl acetate ≤ 5000ppm |
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Hexane ≤ 290ppm |
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Bacterial Endotoxins |
≤ 2.5 EU/mg |
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Total Plate Count |
≤ 100cfu/g |
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Yeasts & Molds |
≤ 10cfu/g |
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E.Coli |
Negative |
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Assay |
≥ 99.0% |
