Prevention of Cytomegalovirus Valganciclovir Hydrochloride CAS No 175865-59-5

• Function: Antiviral
• Grade Standard: Medicine Grade
• Type: Chemical Reagent
• State: Powder
• Volatile: Not Volatile
• Standard: USP
• Model NO.: SAMREAL-0273
• Shelf Life: 2 Years
• Transport Package: Drum
• Specification: 20kg/drum
• Trademark: samreal
• Origin: China

Product Description

Valganciclovir hydrochloride cas no 175865-59-5

Test	Method	Limits	Results
Description	White crystalline powder	White to off-white powder	White powder
Identification	A:Infrared Absorption<197k>	Spectrum similar to reference standard	Complies
	B:Ultraviolet Absorption<197U>	Spectrum similar to reference standard	Complies
	C:Chloride<191>	Conform to the requirements	Complies
Water	USP41 Method I<921>	Not more than 8.0%	4.7%
Isopropyl alcohol	USP41 Method I	Not more than 1.0%	0.4%
Residue on ignition	USP41 <281>	Not more than 0.10%	0.06%
Related impurities(HPLC)	Valganciclovir	-	-
	Ganciclovir	Not more than 1.5%	0.29%
	Methoxymethylguanine	Not more than 0.3%	Complies
	Guanine	Not more than 0.25%	0.09%
	Isovalganciclovir	Not more than 0.5%	Complies
	Monoacetoxy ganciclovir	Not more than 0.15%	0.02%
	Bis-valine easter of ganciclvoir	Not more than 0.1%	Complies
	Homologue of valganciclovir	Not more than 0.25%	Complies
	H	Not more than 0.1%	Complies
	I	Not more than 0.1%	Complies
	Ganciclovir monopropionate	Not more than 0.15%	0.09%
	Valganciclovir dimer (Stereoisomer A)	Not more than 0.1%	Complies
	Valganciclovir dimer (Stereoisomer B)	Not more than 0.1%	Complies
	Valganciclovir dimer (Stereoisomer C)	Not more than 0.1%	Complies
	Ganciclovir mono-N-methylvalinate	Not more than 0.3%	Complies
	Other identified impurity	Not more than 0.1%	Complies
	Unidentified impurity	Not more than 0.1%	Complies
	Total of all impurities	Not more than 3.0%	1.3%
Diastereomer ratio (R and S esters of L-valline)	HPLC Chromatography<621>	45:55 to 55:45	53:47
Residual solvents	GC Chromatography<621>	Isopropanol≤5000ppm	2480ppm
		Methanol≤3000ppm	1390ppm
		Toluene≤890ppm	0ppm
		Methylene chloride≤600ppm	0ppm
		Acetone≤5000ppm	0ppm
Enantiomeric Purity of Valganciclovir	HPLC Chromatography<621>	Not less than 97.0%	98.0%
Assay	HPLC Chromatography<621>	Not less than 97.0% and not more than 102.0% of C14H22N6O5·HCL,calculated on the anhyydrous and solvent-free basis.	99.6%

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