OEM/ODM China Favipiravir Factory - USP 175865-59-5 Valganciclovir hydrochloride for Antiviral – Yibai

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OEM/ODM China Favipiravir Factory - 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
Items	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.

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√ Management layer’s full experience in factory and skilled technicians followers;
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