we have gmp usp34
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% |