Manufacturer Provide High Quality Valganciclovir Hydrochloride CAS 175865-59-5 Valganciclovir HCl
Introduction
Product Name: Valganciclovir hydrochloride
Other Name :L-Valine,2-[(2-aMino-1,6-dihydro-6-oxo-9H-purin-9-yl)Methoxy]-3-hydroxypropylester,hydrochloride(1:1);2-[(2-amChemicalbookino-6-oxo-6,9-dihydro-3H-purin-9-yl)methoxy]-3-hydroxypropyl(2S)-2-amino-3-methylbutanoatehydrochloridehydrate;
CAS NO:175865-59-5
Purity: 99%min
Appearance:White crystalline powder
Molecular formula: C14H23ClN6O5
MW:390.82
Melting Point :162-164°C
Storage :Keep in dark place,Inert atmosphere,Room temperature
Valganciclovir is a DNA polymerase inhibitor. After oral administration, ganciclovir is rapidly hydrolyzed into ganciclovir under the action of intestinal mucosal cell esterase and liver esterase, so its pharmacodynamic characteristics are the pharmacodynamic characteristics of ganciclovir. Ganciclovir can produce ganciclovir triphosphate by enzymatic phosphorylation in virus and cell, which competes with deoxyguanosine triphosphate (dGTP) as the substrate of viral DNA polymerase, thus inhibiting the synthesis of viral DNA and producing anti-CMV activity.
Application of Valganciclovir hydrochloride:
Is used for preventing and treating CMV infection secondary to organ transplant recipients. This drug is a prodrug of ganciclovir, and it is an active valine ester of ganciclovir. After oral administration, it can be rapidly hydrolyzed into ganciclovir by phosphatase in intestinal and liver cells. Its antiviral spectrum and action mechanism are similar to ganciclovir, but its bioavailability is significantly higher than that of ganciclovir. Its oral absorption bioavailability is 62.4%, which is 10 times that of ganciclovir, while its toxicity is greatly reduced..
Items | Standards | Results |
Appearance | White or off-white powder | Off-white powder |
Identification | By HPLC | Complies |
Melting Point | 120ºC~130ºC | 126ºC |
Loss on Drying | ≤1.00% | 0.21% |
Heavy Metals | ≤ 10ppm | Complies |
Sulfated Ash | ≤ 0.10% | 0.03% |
Content | 17.5%~19.5% | 19.3% |
Arsenic Content | ≤ 0.1ppm | 0.09ppm |
Lead VContent | ≤ 3.0ppm | 0.50ppm |
Content | ≤ 0.1ppm | 0.10ppm |
Content | ≤ 0.1ppm | 0.10ppm |
Microbiological Test | Coliforms:Negative | Negative |
Salmonella: Negative | Complies |
Total plate count: ≤1000 CFU/g | Pass |
Yeast&Mold: ≤50 CFU/g | Pass |
Related Substances | Impurity A: ≤0.30% | 0.18% |
Other unknown impurity: ≤0.10% | 0.07% |
Total Impurities: ≤0.50% | 0.42% |
Assay | ≥ 98.0% | 99.50% |
Reference Standard | USP Standard |
Conclusion | The product complied to USP standard. |
Storage | Preserve in tight,light-resistant containers in a cool place |