Irbesartan: angiotensin II receptor blocker (sartan).
Irbesartan testing at Vanguard Laboratory: identity, purity and quantity $250 per sample, with results in 3 to 5 business days.
Irbesartan: 2D structure drawn from the PubChem record (CID 3749).
138402-11-6
C25H28N6O
428.53 g/mol
Angiotensin II receptor blocker (sartan)
Identity: Irbesartan
IUPAC name: 2-butyl-3-[[4-[2-(2H-tetrazol-5-yl)phenyl]phenyl]methyl]-1,3-diazaspiro[4.4]non-1-en-4-one
Method for the $250 identity, purity and quantity test: HPLC-UV purity and assay, LC-MS identity, against a reference standard, with results in 3 to 5 business days.
The USP monograph covers identity by infrared spectroscopy and HPLC retention time, assay by HPLC, organic impurities by HPLC, azide by ion chromatography with conductivity detection, and water content. Full testing to the USP Irbesartan monograph is available and quoted.
Chromatographic purity and mg per unit by the method matched to the compound, identity against a reference standard. 1 unit.
| Add-on test | Price |
|---|---|
| Identity and impurities | |
| FTIR identity | $90 |
| CHNS elemental analysis (carbon, hydrogen, nitrogen, sulfur) | $125 |
| Chiral purity (where a chiral method exists; new methods quoted) | $250 |
| Water, solvents and salt form | |
| Water content by Karl Fischer | $60 |
| Residual solvents | $150 |
| Counterions: chloride, acetate and TFA | $70 |
| Assay | |
| Assay, % w/w (with raw powder purity; $250 together) | +$50 |
| Metals and conformity | |
| Heavy metals: arsenic, cadmium, chromium, mercury and lead | $150 |
| Conformity: purity and quantity on more units from the same lot | $100 per extra unit |
| Microbiology (injectables) | |
| Endotoxin | $210 |
| Sterility or bioburden | $150 |
| Container closure integrity (CCI) | $50 |
| Screening | |
| Fentanyl screen | $50 |
10% off for 10 or more samples.
Need something else? Other tests are available on request.
Purity and quantity is $250 per sample (1 unit) and raw powder purity is $200 for 50 mg, with results in 3 to 5 business days. Send the material sealed and labeled, with the label claim and the form it contains.
No. The $250 test covers identity, purity and quantity by HPLC-UV for purity and quantity and LC-MS for identity. Full testing to the USP Irbesartan monograph is available and quoted.
The tetrazole ring in sartans is often made with azide reagents, so residual azide is a process impurity. Azide has no useful UV absorbance and is measured by ion chromatography, which is quoted separately from the $250 test.
No. Trace nitrosamines such as NDMA and NDEA, which can occur in sartans from some synthesis routes, need a dedicated LC-MS/MS or GC-MS method. That testing is quoted separately.
https://pubchem.ncbi.nlm.nih.gov/compound/3749
Identity facts from the USP monograph header for this compound.
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