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Irbesartan

Irbesartan  be used for Antihypertensive, for the treatment of hypertension

Product : Irbesartan
CAS No.: 138402-11-6
MF: C25H28N6O
MW: 428.53
Purity: 99%
Appearance: White Crystalline Powder
Place of Origin: China
Standard: USP
Certification: SGS
Method of Analysis: HPLC

                   CERTIFICATE OF ANALYSIS

Product name
Irbesartan
CAS No.
138402-11-6
Outer Packing
25kg/drum
Production date
2016-7-28
Shelf life
2019-06
Standard adopted
USP38
Items of analysis
Specification
Results
Character
White to white crystalline powder
White crystalline powder
Solubleness
soluble in ethanol and dichloromethane, which is almost insoluble in water
Identify
 
The absorption of the infrared light of this product should be consistent with the graph of the control
Identify
 
The retention time of the main peak of the supply test solution should be consistent with the retention time of the main peak of the control
Moisture
≤0.5%
0.3%
Hydrazoates
≤10ppm
1ppm

Pb

≤0.002%
<0.002%
 Impurity
 A≤0.2%
0.05%
 Impurity
 ≤0.1
0.02%
 Impurity

Total impurity

≤0.5%

0.11
Assay
98%-102%
99.3%
TOL
≤890ppm
29ppm
Dichloromethane
≤600ppm
30ppm

N,N-D

≤880ppm
11ppm

Ethyl Alcohol

≤5000ppm
19ppm
Conclusion
Qualified
 

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