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API-Capecitabine avec USP35 / pureté 99%

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Informations de base

Modèle: USP35

Description du produit

API-Capecitabine avec USP35 / pureté 99%

Description du produit
À propos de notre Capecitabine

Il est utilisé dans le traitement des cancers suivants: cancer colorectal, cancer du sein, cancer gastrique, cancer œsophagien.

Puhopharmaspecialises dans le contrôle de la qualité et la réduction des impuretés de Capecitabine.
Notre Capecitabine est la meilleure qualité et le prix le plus compétitif en Chine.

La qualité de notre Capecitabine

COA de notre Capecitabine

Test Items		Standard	Results
Appearance		White to off-white crystalline powder	Conforms
Solubility		Freely soluble in methanol;soluble in acetonitrile and in alcohol;sparingly soluble in water	Conforms
Identification		A. By IR spectrum. IR spectrum sample should concordant with spectrum of standard B.By HPLC. The retention time of the major peak of the sample solution corresponds to that of the standard solution,as obtained in the Assay.	Conforms Conforms
Water		Not more than 0.3%	0.05%
Optical Rotation		+96.0°~ +100.0°	+96.8°
Heavy metals		Not more than 20ppm	Conforms
Residue on ignition		Not more than 0.1%	0.03%
Related compounds	Capecitabine related compound A≤0.3%		0.001%
	Capecitabine related compound B≤0.3%		N.D
	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%		0.004%
	[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%		N.D.
	[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%		0.02%
	[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%		0.01%
	2’,3’-Di-O-acetyl-5’-deoxy-5-fluoro-N4-(pentyloxycarbonyl) Cytidine≤0.1%		0.01%
	Individual unspecified impurity≤0.1%		0.02%
	Total unspecified impurities≤0.5%		0.04%
	Total impurities≤1.5%		0.08%
Residual solvents by GC	Methanol ≤3000ppm Ethanol ≤5000ppm Ethyl acetate ≤5000ppm Toluene ≤890ppm Pyridine ≤200ppm Hexane ≤290ppm Dichloromethane ≤600ppm		200ppm 1ppm 20ppm 3ppm 7ppm 6ppm 40ppm
Assay (HPLC)	98%-102.0% (Calculated on the anhydrous and solvent-free basis)		99.8%