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Tests

Specifications

Results

Appearance

White to off- white crystalline powder

White crystalline powder

Solubility

Freely soluble in methanol, soluble in acetonitrile in alcohol, sparingly soluble in water

Conforms

Identification

IR spectrum

HPLC

Spectrum sample should concordant with spectrum of standard

The retention time of the majpeak of the sample solution corresponds to that of the standard solution as obtained in the assay

Conforms

Conforms

Optical rotations

+96.0°~+100°

+96.8°

Water

Not more than 0.3%

0.04%

Residue on ignition

Not more than 0.1%

0.03%

Heavy metals

Not more than 20ppm

<20ppm

Related substances (HPLC)

Impurity A

Impurity B
2’,3’-Di-O-acetyl-5’-deoxy-5-fluorocytidine

5’-Deoxy-5-fluoro-N4-(2-methyl-1-butyloxycarbonyl)cytidine+5’-Deoxy-5-fluoro-N4-(3-methyl-1-butyloxycarbonyl)cytidne

[1-[5-Deoxy-3-O-(5-β-D-ribofuranosyl)-β-D-ribofuraosyl]-5-fluoro-2-oxo-1,2-dibydropytimidin-4-yl]-carbamic acid pentyl ester

1-[5-Deoxy-2-O-(5-β-D-ribofuranosyl)-β-D-ribofuraosyl]-5-fluoro-2-oxo-1,2-dibydropytimidin-4-yl]-carbamic acid pentyl ester

Impurity C

1-[5-Deoxy-2-O-(5-α-D-ribofuranosyl)-β-D-ribofuraosyl]-5-fluoro-2-oxo-1,2-dibydropytimidin-4-yl]-carbamic acid

2’,3’-Di-O-acetyl-5’-deoxy-5-fluoro-N4-(Pentyfoxycarbonyl) Cytidine

Individual unspecified impurity

Total unspecified impurity

Total impurities

Not more than 0.3%

Not more than 0.3%

Not more than 0.1%

Not more than 0.5%

Not more than 0.3%

Not more than 0.2%

Not more than 0.3%

Not more than 0.3%

Not more than 0.1%

Not more than 0.1%

Not more than 0.5%

Not more than 1.5%

0.006%

Not detected

Not detected

0.006%

Not detected

Not detected

Not detected

Not detected

Not detected

0.02%

0.05%

0.06%

Residual solvents by GC

Methanol

Ethanol

Ethyl acetate

Toluene

Pyridine

Hexane

Dichloromethane

Not more than 3000ppm

Not more than 5000ppm

Not more than 5000ppm

Not more than 890ppm

Not more than 200ppm

Not more than 290ppm

Not more than 600ppm

200ppm

2ppm

30ppm

3ppm

20ppm

2ppm

70ppm

Assay ( 0n dried basis)

98.0%~102.0%

99.2%

Conclusion

Complies with USP34 Standard