Characteristics :White or almost white powder Identification :Conforms Specific rotation :-8.5°~ -11.5° PH :4.0~6.0 …
Characteristics :White or almost white powder
Identification :Conforms
Specific rotation :-8.5°~ -11.5°
PH :4.0~6.0
Water Anhydrous: ≤2.0%
Hydrous: 5.0%~9.0%
Heavy metals :≤10ppm
Palladium :≤10ppm
Palladium :≤10ppm
Residue on ignition :≤0.1%
Organic impurities Related compound E: ≤0.2%
Related compound F: ≤0.1%
Related compound G: ≤0.05%
Acyclovir alaninate: ≤0.2%
Related compound C: ≤0.3%
Related compound D: ≤0.5%
Acyclovir isoleucinate: ≤0.2%
N-formyl valacyclovir: ≤0.8%
Guaninyl valacyclovir: ≤0.2%
Bis valacyclovir: ≤0.3%
Any other individual impurity:≤0.1%
Total unspecified impurities: ≤0.2%
Guanine & Acyclovir: ≤2.0%
Related compound A: ≤0.2%
D-valacyclovir: ≤3.0%
Total impurities(1+2+3): ≤5.0%
Assay(HPLC on anhydrous and solvent free basis) :95.0%~102.0%
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