AppearanceWhiteoralmostwhitecrystallinepowder. Specificrotation:Between-8.5°and-11.5° Identification1.HPLCTheretentiontimeofthem…
AppearanceWhite or almost white crystallinepowder.
Specific rotation : Between-8.5°and -11.5°
Identification 1. HPLCThe retention time of the major peak in the chromatogram of the Assay
preparation corresponds to that in the chromatogram of the standard preparation obtained as directed in the Assay.
2. IR-spectroscopy. IR-spectrum of preparation should have fully coincidence with IR-spectrum
of Valaciclovir hydrochloride RS.
3. Qualitative reaction for chlorides.Should pass the test.
pH: From 4.0 to 6.0
Water: NMT 8.0%
Related substances(HPLC):acyclovir – NMT 1.5 %
Sum of impurity peak areas NMT. that of
valaciclovir peak area of standard soln.
Sulphated ash :NMT 0.1%
Heavy metals :NMT 20ppm
Assay:NLT 98.0 % calculated on the anhydrous basis
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