|
Product name
|
Azilsartan
|
|
Molecular Formula
|
C25H20N4O5
|
|
Molecular Weight
|
456.45
|
|
CAS No.
|
147403-03-0
|
|
Quality Standard
|
99% up,JP /
GMP/ PMDA/DMF, medical grade
|
|
Appearance
|
White powder
|
|
Analysis Items
|
Specification
|
Result
|
|
Appearance
|
White to almost white powder
|
Almost white powder
|
|
Identification
|
Meet reference standard
|
Conform
|
|
Loss on drying
|
NMT 0.5%
|
0.1% below
|
|
Specified impurity (RRT2.1)
|
NMT 0.1%
|
0.01% below
|
|
Specified impurities(RRT2.4)
|
NMT0.1%
|
0.01%
|
|
Any other individual impurity
|
NMT 0.1.%
|
0.04%
|
|
Total impurity
|
NMT 0.5%
|
0.08%
|
|
Ethanol
|
NMT 5000ppm
|
37ppm
|
|
Acetone
|
NMT 5000ppm
|
10ppm below
|
|
Assay
|
NLT 99% calculated on the dried basis
|
99.6%
|
Azilsartan is an angiotensin II receptor inhibitor that
lowers blood pressure by blocking the activity of the angiotensin II receptor,
compared with angiotensin-converting enzyme inhibitor (ACEI) antihypertensive
drugs. It has the advantage of smooth blood pressure, does not cause dry cough.
