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Merck

PHR1443

Irbesartan

Pharmaceutical Secondary Standard; Certified Reference Material

Sinónimos:

2-Butyl-3-[[2′-(2H-tetrazol-5-yl)[1,1′-biphenyl]-4-yl]methyl]-1,3-diazaspiro[4.4]non-1-en-4-one

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Fórmula empírica (notación de Hill):
C25H28N6O
Número CAS:
138402-11-6
Peso molecular:
428.53
NACRES:
NA.24
PubChem Substance ID:
329822604
UNSPSC Code:
41116107
MDL number:
MFCD00864464

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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)

SMILES string

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

InChI key

YOSHYTLCDANDAN-UHFFFAOYSA-N

grade

certified reference material, pharmaceutical secondary standard

agency

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

Quality Level

300

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 and EP 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.
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.

Clase de almacenamiento

11 - Combustible Solids

wgk

WGK 3

flash_point_f

Not applicable

flash_point_c

Not applicable

Certificados de análisis (COA)

Busque Certificados de análisis (COA) introduciendo el número de lote del producto. Los números de lote se encuentran en la etiqueta del producto después de las palabras «Lot» o «Batch»

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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)
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)
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)
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)
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