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Product Name | Gliclazide BP | ||||
Quanlity Standard: | BP-2007, EP 5.0 | ||||
ITEM | SPECIFICATION | ||||
Characters: | A white or almost white powder | ||||
Identification: | Conform to the spectrum of the CRS Gliclazide. | ||||
Melting point: | 162-166 | ||||
Solubility: | Practically insoluble in water; freely soluble in dichloromethane; sparingly soluble in acetone;slightly soluble in ethanol (96%). | ||||
Loss on drying: | ≤0.25% | ||||
Sulphated ash: | ≤0.10% | ||||
Heavy metals: | ≤10ppm | ||||
Assay: | 99.0-101.0% | ||||
Related substances: | 1-(hexahydrocyclopentacpyrrol-2(1H)-y1)-3-2-methylpheny1)sulphony1urea ≤0.1% | ||||
Any other impurity ≤0.1% | |||||
Total impurities ≤0.2% | |||||
2-nitroso-octahydro-cyclopentacpyrrole ≤ 2ppm |
GLICLAZIDE BP