Item

Standard

Result

Description

White crystalline powder

conforms

Specific ratation

-149°~-151°

-150.2

Melting point

192℃~196℃ degradation on melting point

194.5℃

Identification

Chemical

Positive reaction

positive

IR

Should correspond to RS

conforms

Acidity

PH 2.0~3.0(2.5mg/ml)

2.55

Related substance

≤1.0%

0.33%

Loss on drying

≤0.5%

0.21%

Heavy metals

≤10 ppm

Conforms

Residue on ignition

≤0.1%

Conforms

Residual solvent

Methanol

≤3000 ppm

Conforms

dichloromethane

≤600 ppm

Conforms

Assay C9H12N2O1SNLT(on dried basis)

98.5% min

99.5%

Conclusion

Comply with the in-house penciclovir