Irbesartan

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.

Structure

2D structure of Irbesartan

Irbesartan: 2D structure drawn from the PubChem record (CID 3749).

Compound data

CAS number

138402-11-6

Formula

C25H28N6O

Molecular weight

428.53 g/mol

Type

Angiotensin II receptor blocker (sartan)

Structure and names

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

How Vanguard tests Irbesartan

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.

What's reported

  • Purity, as percent of total peak area
  • Quantity, against the label claim
  • Identity, reported as match or no match against the reference standard
  • With monograph testing (quoted): the monograph’s tests against its limits

Tests and prices

$250

Chromatographic purity and mg per unit by the method matched to the compound, identity against a reference standard. 1 unit.

$200

Chromatographic purity on bulk powder. 50 mg.

Add-on tests

Add-on testPrice
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.

Sample amount and turnaround

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.

Salts, forms and compendial references

  • Irbesartan (CAS 138402-11-6)
  • Tell us the salt or form the label states, so quantity is reported on the same basis.

Questions about Irbesartan testing

Is the $250 test the same as USP monograph testing?

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.

Why does the USP monograph test irbesartan for azide?

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.

Does the $250 test look for nitrosamines?

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.

Sources

https://pubchem.ncbi.nlm.nih.gov/compound/3749

Identity facts from the USP monograph header for this compound.

Order

Start an order online, or send the compound name and the tests you need for a quote.