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Best quality Entecavir Hydrate - USP 175865-59-5 Valganciclovir hydrochloride for Antiviral – Yibai

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Best quality Entecavir Hydrate - USP 175865-59-5 Valganciclovir hydrochloride for Antiviral – Yibai Detail:

Product name Valganciclovir hydrochloride
Synonyms L-Valine,2-[(2-aMino-1,6-dihydro-6-oxo-9H-purin-9-yl)Methoxy]-3-hydroxypropylester,hydrochloride(1:1);2-[(2-amino-6-oxo-6,9-dihydro-3H-purin-9-yl)methoxy]-3-hydroxypropyl(2S)-2-amino-3-methylbutanoatehydChemicalbookrochloridehydrate;L-Valine,2-[(2-amino-1,6-dihydro-6-oxo-9H-purin-9-yl)methoxy]-3-hydroxypropylester,monohydrochloridehydrate
CAS No. 175865-59-5
Appearance White or off-white crystalline powder
Molecular Formula C14H22N6O5.HCl
Molecular Weight 390.83
Usage Pharmaceutical Grade or Research purpose
Packing As per your request
Storage Preserve in tight,light-resistant containers in a cool place

 

Valganciclovir hydrochloride Cas: 175865-59-5

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Standard

Results

Appearance White or off-white crystalline powder white powder
Identification Infrared Absorption:Corresponds to that of reference standardUltraviolet Absorption:Corresponds to that of reference standardA solution in water (1 in 20) meets the requirements of the tests for Chloride Complies Complies

 

Complies

Isopropyl alcohol ≤1.0% 0.13%
Water ≤8.0% 4.5%
Heavy metals ≤20ppm Complies
Pd ≤10ppm <10ppm
Residue on ignition ≤0.1% 0.02%
Related impurities Valganciclovir: /Ganciclovir: ≤1.5%Guanine: ≤1.5%

Methoxymethylguanine: ≤0.3%

Isovalganciclovir: ≤0.5%

Monoacetoxyganciclovir:  ≤0.15%

Bis-valine easter of ganciclovir: ≤0.1%

Homologue of valganciclovir: ≤0.25%

Imp H:  ≤0.1%

Imp I: ≤0.1%

Ganciclovir monopropionate: ≤0.15%

Valganciclovir dimer (stereoisomer A): ≤0.1%

Valganciclovir dimer (stereoisomer B): ≤0.1%

Valganciclovir dimer (stereoisomer C): ≤0.1%

Single other identified impurity: ≤0.1%

Total other identified impurity: ≤0.1%

Ganciclovir mono-N-methyl valinate (Test 2):≤0.3%

Single unidentified impurity (Test 1 and 2): ≤0.1 %

Total unidentified impurity (Test 1 and 2): ≤0.25%

Total impurities (Test 1 and Test 2): ≤3.0

/0.02%0.01%

0.03%

0.02%

ND

0.04%

0.01%

0.01%

0.004%

ND

ND

ND

ND

Max 0.04%

0.04%

 

0.02%

Max 0.02%

0.13%

0.78%

Diastereomer ratio 45:55 to 55:45 54:46
Enantiomeric purity of valganciclovir ≥97.0% 99.9%
HPLC assay 97.0%~102.0%  98.8%
Conclusion: complies with USP40.

Company Information

√ Management layer’s full experience in factory and skilled technicians followers;
√ Quality is always our top consideration, Strict QC system;
√ 11 years experienced exporting sales team;
√ Independent R&D lab;
√ Two signed long term GMP workshops;
√ Rich resources of plenty idle factories for customized project;
√ High Efficiency working team with consistent path.
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Best quality Entecavir Hydrate - USP 175865-59-5 Valganciclovir hydrochloride for Antiviral – Yibai detail pictures

Best quality Entecavir Hydrate - USP 175865-59-5 Valganciclovir hydrochloride for Antiviral – Yibai detail pictures

Best quality Entecavir Hydrate - USP 175865-59-5 Valganciclovir hydrochloride for Antiviral – Yibai detail pictures


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