Valacyclovir hydrochloride USP 97%min Pharmaceutical API Anti hepatitis Disease resistant poison made in china CAS NO.124832-27-5

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%