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PHR1443

Supelco

Irbesartan

Pharmaceutical Secondary Standard; Certified Reference Material

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Synonym(s):
2-Butyl-3-[[2′-(2H-tetrazol-5-yl)[1,1′-biphenyl]-4-yl]methyl]-1,3-diazaspiro[4.4]non-1-en-4-one
Empirical Formula (Hill Notation):
C25H28N6O
CAS Number:
138402-11-6
Molecular Weight:
428.53
MDL number:
MFCD00864464
UNSPSC Code:
41116107
PubChem Substance ID:
329822604
NACRES:
NA.24

grade

certified reference material
pharmaceutical secondary standard

Quality Level

300

Agency

traceable to BP 1093
traceable to Ph. Eur. Y0001166
traceable to USP 1347700

API family

irbesartan

CofA

current certificate can be downloaded

packaging

pkg of 1 g

technique(s)

HPLC: suitable
gas chromatography (GC): suitable

application(s)

pharmaceutical (small molecule)

format

neat

storage temp.

2-8°C

SMILES string

CCCCC1=NC2(CCCC2)C(=O)N1Cc3ccc(cc3)-c4ccccc4-c5nnn[nH]5

InChI

1S/C25H28N6O/c1-2-3-10-22-26-25(15-6-7-16-25)24(32)31(22)17-18-11-13-19(14-12-18)20-8-4-5-9-21(20)23-27-29-30-28-23/h4-5,8-9,11-14H,2-3,6-7,10,15-17H2,1H3,(H,27,28,29,30)

InChI key

YOSHYTLCDANDAN-UHFFFAOYSA-N

Gene Information

human ... AGTR1(185)

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General description

Irbesartan is a potent, long-acting “sartan” class, nonpeptide, angiotensin II receptor antagonist utilized for the management of hypertension as well as heart failure in clinical patients. It shows high selectivity for the AT1 subtype (angiotensin I), and effectively reduces the probabilities of cardiac failure, myocardial infarction, sudden death, etc.
Pharmaceutical secondary standards for application in quality control, provide pharma laboratories and manufacturers with a convenient and cost-effective alternative to the preparation of in-house working standards.

Application

Irbesartan may be used as a pharmaceutical reference standard for the determination of the analyte in pharmaceutical formulations and combined dosage forms by chromatography and spectrophotometric techniques.
These Secondary Standards are qualified as Certified Reference Materials. These are suitable for use in several analytical applications including but not limited to pharma release testing, pharma method development for qualitative and quantitative analyses, food and beverage quality control testing, and other calibration requirements.

Analysis Note

These secondary standards offer multi-traceability to the USP, EP and BP primary standards, where they are available.

Other Notes

This Certified Reference Material (CRM) is produced and certified in accordance with ISO 17034 and ISO/IEC 17025. All information regarding the use of this CRM can be found on the certificate of analysis.

Footnote

To see an example of a Certificate of Analysis for this material enter LRAC2897 in the slot below. This is an example certificate only and may not be the lot that you receive.

WGK

WGK 3

Flash Point(F)

Not applicable

Flash Point(C)

Not applicable

Certificates of Analysis (COA)

Search for Certificates of Analysis (COA) by entering the products Lot/Batch Number. Lot and Batch Numbers can be found on a product’s label following the words ‘Lot’ or ‘Batch’.

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Determination of hydrochlorothiazide and irbesartan in pharmaceuticals by fourth-order UV derivative spectrophotometry
Vetuschi C, et al.
Il Farmaco (Societa Chimica Italiana : 1989), 60(8), 665-670 (2005)
H-Point Standard Addition Method for Simultaneous Spectrophotometric Determination of Irbesartan, hydrochlorothiazide and Telmisartan in tablets
Sivasubramanian L and Lakshmi KS
International Journal of Research in Pharmacy and Chemistry, 4(2), 373-380 (2014)
A novel dilute and shoot HPLC assay method for quantification of irbesartan and hydrochlorothiazide in combination tablets and urine using second generation C18-bonded monolithic silica column with double gradient elution
Koyuturk S, et al.
Journal of Pharmaceutical and Biomedical Analysis, 97(2), 103-110 (2014)
Electrochemical determination of antihypertensive drug irbesartan in pharmaceuticals
Gupta VK, et al.
Analytical biochemistry, 410(2), 266-271 (2011)
Simultaneous determination of olmesartan medoxomil and irbesartan and hydrochlorothiazide in pharmaceutical formulations and human serum using high performance liquid chromatography
Sultana N, et al.
Se Pu / Chinese Journal of Chromatography, 26(5), 544-549 (2008)
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