99% up by HPLC Azilsartan Medoxomil Potassium 1417576-00-1

Product Information

Product name

Azilsartan Medoxomil Potassium；

(5-methyl-2-oxo-1,3-dioxol-4-yl)methyl 2-oxo-3-((2’-(5-oxo-4,5-dihydro-1,2,4-oxadiazol-3-yl)-[1,1’-biphenyl]-4-yl)methyl)-2,3-dihydro-1H-benzo[d]imidazole-4-carboxylate

CAS No.

1417576-00-1

Molecular Formula

C28H20N4O8

Molecular Weight

540.489

Quality Standard

98% up by HPLC

Appearance

White or almost white crystalline powder

COA

ANALYSIS

SPECIFICATION

RESULTS

Appearance

White or almost white crystalline powder

White crystalline powder

Solubility

Practically insoluble in water

Conforms

Identification

The retention time of the main peak should be consistent with the RS

Conforms

The infrared absorption spectrum is concordant with that of RS

Conforms

It gives the reaction of potassium(2).

Positive

Related substances

Impurity C ≤ 0.15%

ND

Impurity A ≤ 1.5%

0.2%

Unspecified impurities ≤ 0.10%

0.04%

Total impurities ≤ 2.0%

0.4%

2-Ethylhexanoic acid

≤0. 5%

0.20%

Residual solvents

Ethanol ≤ 0.5%

ND

Acetone ≤ 0.5%

0.01%

Dichloromethane ≤ 0.06%

ND

Tert-Butylmethyl ether ≤ 0.5%

0.10%

Tetrahydrofuran ≤ 0.072%

ND

n-Heptane ≤ 0.5%

ND

Butyl acetate ≤ 0.5%

ND

Water

≤ 0.5%

0.09%

Heavy metals

≤ 20ppm

Conforms

Assay

≤98.0% - 102.0%(anhydrous substance)

99.7%

Conclusion

The sample complies with the Requirements of In House Specifications.

Usage