Cas No. :138402-11-6
Specs:USP/EP
Product IRBESARTAN
CAS NO;138402-11-6
Standard;USP
MF;C25H28N6O
MW;428.53
Specification:
Test Items Standard Result
Description White crystalline powder Complies
Solubility Slightly soluble in alcohol and in methylene chloride, practically insoluble in water Complies
Identification:IR/HPLC Similar to standard Complies
Water ≤0.5% 0.29%
Residue on ignition ≤0.1% 0.04%
Azide ≤0.001% Complies
Heavy metal ≤0.002% Complies
Related compounds
Total compounds ≤0.5% 0.31%
Releated compounds A ≤0.2% 0.05%
Any other compound ≤0.1% 0.04%
Assay 98.0%-102.0% (on anhydrous basis) 99.5%
Residual solvents Ethanol≤5000ppm Not detected
Toluene≤890ppm 75ppm
Dichloromethane≤600ppm Not detected
N,N-Dimethylformamide≤880ppm Not detected
t-Butyl methyl ether≤5000ppm Not detected
Conclusion It complies with all the requirements of USP35
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3. R&D use in accordance with (1) 35 USC 271(e)+A13(1) in the U.S.; (2) Section 69.1 of Japanese Patent Law in Japan; (3) Section 11, No. 2 of the German Patent Act of 1981 in Germany; (iv) Section 60, Paragraph 5b of the U.K. Patents Act of 1977 in the U.K.; (4) Sections 55.2(1) and 55.2(6) and other common law exemptions of Canadian patent law; (5) Section 68B of the Patents Act of 1953 in New Zealand together with the amendment of same by the Statutes Amendment Bill of 2002; (6) such related legislation and/or case law as may be or become applicable in the aforementioned countries; and (7) such similar laws and rules as may apply in various other countries.
