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PHR1855

Supelco

Telmisartan

Pharmaceutical Secondary Standard; Certified Reference Material

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Synonym(s):
Telmisartan, 4′[(1,4′-Dimethyl-2′-propyl[2,6′-bi-1H-benzimidazol]-1′-yl)methyl][1,1′-biphenyl]-2-carboxylic acid, BIBR 277
Empirical Formula (Hill Notation):
C33H30N4O2
CAS Number:
Molecular Weight:
514.62
MDL number:
PubChem Substance ID:
NACRES:
NA.24

grade

certified reference material
pharmaceutical secondary standard

Quality Level

agency

traceable to Ph. Eur. Y0000648
traceable to USP 1643419

API family

telmisartan

CofA

current certificate can be downloaded

packaging

pkg of 500 mg

technique(s)

HPLC: suitable
gas chromatography (GC): suitable

application(s)

pharmaceutical (small molecule)

format

neat

storage temp.

2-8°C

SMILES string

CCCc1nc2c(C)cc(cc2n1Cc3ccc(cc3)-c4ccccc4C(O)=O)-c5nc6ccccc6n5C

InChI

1S/C33H30N4O2/c1-4-9-30-35-31-21(2)18-24(32-34-27-12-7-8-13-28(27)36(32)3)19-29(31)37(30)20-22-14-16-23(17-15-22)25-10-5-6-11-26(25)33(38)39/h5-8,10-19H,4,9,20H2,1-3H3,(H,38,39)

InChI key

RMMXLENWKUUMAY-UHFFFAOYSA-N

Gene Information

human ... AGTR1(185)

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General description

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.

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.

Telmisartan belongs to the class of angiotensin II receptor antagonists (ARAs) used in the treatment of hypertension.

Application

This pharmaceutical secondary standard can also be used as follows:
  • Reversed-phase high-performance liquid chromatography (RP-HPLC) method-based multi-analysis of rosuvastatin, telmisartan, ezetimibe, and atorvastatin in pharmaceutical dosage formulations
  • RP-HPLC analysis of telmisartan in the presence of its three impurities in its tablet formulation following an analytical quality-by-design (AQbD) approach
  • Multi-determination of hydrochlorothiazide, amlodipine, and telmisartan by HPLC combined with spectrometric techniques without derivatization
  • Simultaneous estimation of telmisartan and hydrochlorothiazide by micellar high-pressure liquid chromatography and spectrophotometry-based methods in their combined tablet formulations
  • RP-HPLC method-based determination of four cardiovascular drugs—atorvastatin, simvastatin, telmisartan, and irbesartan in bulk drugs and tablet dosage forms, following ICH guidelines

Biochem/physiol Actions

Telmisartan is a non-peptide AT1 angiotensin receptor antagonist.

Analysis Note

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

Footnote

To see an example of a Certificate of Analysis for this material enter LRAC3179 in the Documents slot below. This is an example certificate only and may not be the lot that you receive.

Storage Class

11 - Combustible Solids

wgk_germany

WGK 2

flash_point_f

Not applicable

flash_point_c

Not applicable


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