Valsartan 137862-53-4 N-(1-OXOPENTYL)-N-[[2'-(1H-TETRAZOL-5-YL)[1,1'-BIPHENYL]-4-YL]METHYL]-L-VALINE;VALSARTAN;CGP-48933;DIOVAN;3-methyl-2-[pentanoyl-[[4-[2-(2h-tetrazol-5-yl)phenyl]phenyl]methyl]amino]-butanoic acid;VALSA
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ITEMS |
SPECIFICATION |
|
Appearance |
White or off white powder |
|
Solubility |
Very soluble in methanol and ethanol .sparingly soluble in chloroform practically insoluble in water |
|
Identification |
||
--IR |
Similar to standard |
|
--HPLC |
Similar to standard |
|
Absorbance |
NMT0.02 at 420nm(1/20 in methanol ) |
|
Water |
NMT 2.00% |
|
Residue on ignition |
NMT 0.1% |
|
Heavy metals |
NMT 0.001% |
|
Related compounds Related compounds A Related compounds B Related compounds C Any other individual impurity Total impurities(not include related compound A ) |
NMT1.0% NMT0.2% NMT0.1% NMT0.1% NMT0.3% |
|
Assay (HPLC) |
NLT98.0% and NMT102.0% Calculated on the anhydrous basis |
|
Residual solvents by GC Hexanes Ethylacetate Methylenechloride Xylene (mixture) |
NMT290ppm NMT5000ppm NMT600ppm NMT2170ppm |
|
CONCLUSION: CONFORMS TO THE USP33 |
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