99.9% up USP standard GMP certified DMF documents API Valsartan powder

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1 Kilogram	Negotiable

1 Kilogram

Negotiable

valsartan valsartan powder api valsartan

Why is SINOWAY:

1) Specialized in pharmaceutical and healthcare industrial for 34 years.

2) ISO 9001:2015 & SGS audited supplier .

3) Accept various payment terms : T.T 30-60 days.

4) We have warehouse in USA with quickly shipment .

5) We can do different terms of FOB ,CIF/CIP ,DDP ...

1. Basic informaiton for the 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

2. Function for the valsartan

Treat the hypertension

3. Specification for the valsartan

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