卡培他滨

Test Items Standard Results Identification A:Infrared Absorption B:the retention time of the major peak in the chromatogram of the Assay preparation corresponds to that in the chromatogram of the Standard preparation,as obtained in the Assay Conform Conform Appearance White to off-white powder Conform water Not more than 0.3% 0.2% Specific rotation +96.0°-+100.0° +97. 3° Heavy metals Not more than 20ppm Conform Rdsidue on ignition NMT0.1% 0.02% Related compounds Capecitabine related compoundA≤0.3% N.D. Capecitabine related compoundB≤0.3% 0.01% 2’,3’-Di-O-acetyl-5’-deoxy-5-fluorocytidine≤0.1% N.D. 5’-Deoxy-5-fluoro-N4-(2-methyl-1-butyloxycarbonyl) cytidine+5’-Deoxy-5-fluoro-N4-(3-methyl-1-butyloxy carbonyl) cytidine≤0.5% 0.003% [1-[5-Deoxy-3-O-(5-β-D-ribofuranosyl)- β-D-ribofuranosyl] -5-fluoro-2-oxo-1,2-dihydropyrimidin-4-yl]-carbamic acid pentyl ester≤0.3% 0.004% [1-[5-Deoxy-2-O-(5-β-D-ribofuranosyl)- β-D-ribofuranosyl] -5-fluoro-2-oxo-1,2-dihydropyrimidin-4-yl]-carbamic acid pentyl ester≤0.2% N.D. Capecitabine related compound C≤0.3% 0.03% [1-[5-Deoxy-2-O-(5-α-D-ribofuranosyl)- β-D-ribofuranosyl] -5-fluoro-2-oxo-1,2-dihydropyrimidin-4-yl]-carbamic acid pentyl este≤0.3% N.D. 2’,3’-Di-O-acetyl-5’-deoxy-5-fluoro-N4-(pentyloxycarbonyl) Cytidine≤0.1% N.D. Individual unspecified impurity≤0.1% 0.01% Total unspecified impurities≤0.5% 0.02% Total impurities≤1.5% 0.07% Assay(HPLC) 98%-102.0% 99.3% Ethyl acetate ≤5000PPM 88ppm