CAS No:175865-59-5
Shelf life:2 years
Package:20kg/drum or according to customers’ requirements.
The detailed specifications are as below:
| Items | Standard |
| Description | White to off-white powder |
| Identification | A:Infrared Absorption<197K>:Spectrum similar to reference standard |
| B:Ultraviolet Absorption<197U>:Spectrum similar to reference standard | |
| C:Chloride<191>:Conform to the requirements | |
| Water | Not more than 8.0% |
| Isopropyl alcohol | Not more than 1.0% |
| Residue on ignition | Not more than 0.10% |
| Related impurities(HPLC) | Valganciclovir:- |
| Ganciclovir:Not more than 1.5% | |
| Guanine:Not more than 0.25% | |
| Methoxymethylguanine:Not more than 0.3% | |
| Isovalganciclovir:Not more than 0.5% | |
| Monoacetoxy ganciclovir:Not more than 0.15% | |
| Bis-valine easter of ganciclvoir:Not more than 0.1% | |
| Homologue of valganciclovir:Not more than 0.25% | |
| H:Not more than 0.1% | |
| I:Not more than 0.1% | |
| Ganciclovir monopropionate:Not more than 0.15% | |
| Valganciclovir dimer(Stereoisomer A):Not more than 0.1% | |
| Valganciclovir dimer(Stereoisomer B):Not more than 0.1% | |
| Valganciclovir dimer(Stereoisomer C):Not more than 0.1% | |
| Ganciclovir mono-N-methyl valinate:Not more than 0.3% | |
| Other identified impurity:Not more than 0.1% individual≤0.25% total | |
| Unidentified impurity:Not more than 0.1% individual≤0.25% total | |
| Total of all impurities:Not more than 3.0% | |
| Diastereomer ratio(R and S esters of L-valine) | 45:55 to 55:45 |
| Residual solvents | Isopropanol≤5000ppm |
| Methanol≤3000ppm | |
| Toluene≤890ppm | |
| Methylene chloride≤600ppm | |
| Acetone≤5000ppm | |
| Enantiomeric purity of Valganciclovir | Not less than 97.0% |
| Assay | Not less than 97.0% and not more than 102.0% of C14H22N6O5·HCl,calculated on the anhydrous and solvent-free basis. |