Valacyclovir Hydrochloride

Items

Specification

Appearance

White or off-white powder

Related Substances (%)

Valacyclovir related compound E NMT 0.2%

Valacyclovir related compound F NMT 0.1%

Valacyclovir related compound G NMT 0.05%

Acyclovir Alaninate NMT 0.2%

Valacyclovir related compound C NMT 0.3%

Valacyclovir related compound D NMT 0.5%

Acyclovir Isoleucinate NMT 0.2%

N-formyl Valacyclovir NMT 0.8%

Guaninyl Valacyclovir NMT 0.2%

Bis Valacyclovir NMT 0.3%

Any unspecified impurity NMT 0.1%

Guanine & Acyclovir NMT 2.0%

Acyclovir related compound A NMT 0.2%

D-valacyclovir NMT 3.0%

Total organic impurities NMT 5.0%

Water (%)

NMT 5.0% ~ 11.0%

Palladium

NMT 10ppm

Residue on ignition

NMT 0.1%

Specific rotation

-64 ~ -69

Residual solvents

Eethanol NMT 0.5%

Acetone NMT 0.5%

Methanol NMT 0.3%

Formic acid NMT 0.5%

DMF NMT 0.088%

Toluene NMT 0.089%

Benzene NMT 0.0002%

Assay (%)

95.0%~102.0%

Standard

USP43