| Category : |
Intermediates/Pharmaceutical intermediates |
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| CAS NO : |
138402-11-6 |
| EC NO : |
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| MF : |
C25H28N6O |
| MW : |
428.5294 |
| Specification : |
USP/EP |
| Packing : |
25kg/drum |
| Product description : |
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
Patent Disclaimer:
1. Products protected by valid patents are not offered for sale in jurisdictions where the sale of such products constitutes a patent infringement. The current list only reflects the products and technologies that are available, under development: note that some products may be developed or produced for internal and experimental uses with no commercal aim.
2. Sales of products are limited to those allowed by Chapter VII PLPRC 63, the above includes Research and development quantities.
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.
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| Synonyms : |
Irbesartan (GMP);3-butyl-2-[[4-[2-(2h-tetrazol-5-yl)phenyl]phenyl]methyl]-2,4-diazaspiro[4.4]non-3-en-1-one;2-BUTYL-3-[[2'-(1H-TETRAZOL-5-YL)[1,1'-BIPHENYL]-4-YL]METHYL]-1,3-DIAZASPIRO[4.4]NON-1-EN-4-ONE;BMS-186295;AVAPRO;APROVEL;SR-47436;2-butyl-3-{[2'-(2H-tetrazol-5-yl)biphenyl-4-yl]methyl}-1,3-diazaspiro[4.4]non-1-en-4-one; |
| Molecular Structure : |
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