|
Sinoway Industrial Co.Ltd.
|
Product name
|
Irbesartan
|
CAS No.
|
138402-11-6
|
Molecular Formula
|
C25H28N6O
|
Molecular Weight
|
428.53
|
Quality Standard
|
98% up, USP/ EP
|
Appearance
|
White to almost white powder
|
ITEMS
|
STANDARDS
|
RESULTS
|
Appearance
|
White to off-white powder
|
White powder
|
Identification
|
Infrared absorption:
The IR spectrum is consistent with that obtained with the reference
|
Conforms
|
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
|
Water
|
NMT 0.5%
|
0.24%
|
Limit or Azide
|
NMT10ppm
|
Not detected
|
Heavy metals
|
NMT0.002%
|
Conforms
|
Related compounds
(HPLC)
|
Compound A NMT0.2%
|
0.01%
|
Any other impurity NMT0.1%
|
0.04%
|
Total impurity NMT0.5%
|
0.09
|
Residual solvents(GC)
|
Ethanol NMT 5000ppm
|
2307 ppm
|
Toluene NMT 890ppm
|
238 ppm
|
Dichloromethane NMT3000 ppm
|
Not detected
|
N,N-Dimethylformamide NMT880 ppm
|
Not detected
|
T-butyl Methyl Ether NMT 5000 ppm
|
Not detected
|
Assay
|
98.0—102.0%
|
99.2%
|
Conclusion
|
The analysis results show that this batch of irbesartan conforms to USP
|
Function of Irbesartan
Irbesartan is an angiotensin Ⅱ (Angiotensin Ⅱ, Ang Ⅱ) receptor inhibitor, can inhibit the conversion of Ang Ⅰ to Ang Ⅱ, can specifically antagonize the angiotensin converting enzyme 1 receptor (AT1), the antagonism of AT1 is greater than AT28500 Double, by selectively blocking the binding of AngⅡ and AT1 receptors, inhibiting vasoconstriction and the release of aldosterone, resulting in a hypotensive effect. This product does not inhibit angiotensin converting enzyme (ACE), renin, other hormone receptors, nor does it inhibit ion channels related to blood pressure regulation and sodium balance. It is mainly used for the treatment of essential hypertension and type 2 diabetic nephropathy with hypertension. |
Send Inquiry
|
Pharma Sources Insight June 2024: Globalization on the Go
