Valsartan

Product Name

Valsartan

Other name

N-(1-Oxopentyl)-N-[[2'-(1H-tetrazol-5-yl)[1,1'-biphenyl]-4-yl]methyl]-L-valine

Diovan

Quality

USP36

Cas:

137862-53-4

Molecular Formula

C₂₄H₂₉N₅O₃

Molecular Weight

435.52

Items

Standard,

Results

Appearance

White or almost white hygroscopic powder

Almost white hygroscopic powder

solubility

Freely soluble in anhydrous ethanol, sparingly soluble in Methylene chloride, Practically insoluble in water

conforms

Absorbance

NMT 0.02 at 420nm (1/20 Methanol solution)

0.01

Identification

A: IR infared absorption spectrum is identical to that of valsartan reference standard

B: The retention time of the major peak in the chromatogram of the assay preparation corresponds to that in the chromatogram of the standard preparation, as obtained in the assay

Conforms

conforms

Water

NMT 2.0%

1.0%

Residue on ignition

NMT 0.1%

< 0.1%

Heavy metals

NMT 0.001%

< 0.001%

Related compounds

Related compound A

NMT 1.0%

0.31%

Related compound B

NMT 0.2%

0.02%

Related compound C

NMT 0.1%

N.D

Any other unspecified impurity

NMT 0.1%

0.03%

Total impurities ( not Include related compound A)

NMT 0.3%

0.17%

Assay

98.0-102% of C₂₄H₂₉N₅O₃,Calculated on the anhydrous basis

100.5%

Residual Solvents

Ethylacetate

NMT5000PPM

1249PPM

Methylenechloride

NMT 600PPM

N.D

toluene

NMT 890PPM

5PPM

Methanol

NMT 3000PPM

N.D

Dimethylformamide

NMT880PPM

N.D

Particle size

reference

D50: 40.56UM

D90: 71.15UM

Bulk density

reference

0.31g/ml

Tapped density

reference

0.45g/ml

Conclusion

It conforms to USP36