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Key Documents

PHR1315

Supelco

Valsartan

Pharmaceutical Secondary Standard; Certified Reference Material

Sinônimo(s):

Valsartan, N-(1-Oxopentyl)-N-[[2′-(2H-tetrazol-5-yl)[1,1′-biphenyl]-4-yl]methyl]-L-valine

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About This Item

Fórmula empírica (Notação de Hill):
C24H29N5O3
Número CAS:
Peso molecular:
435.52
Número MDL:
Código UNSPSC:
41116107
ID de substância PubChem:
NACRES:
NA.24

grau

certified reference material
pharmaceutical secondary standard

Nível de qualidade

Agency

traceable to BP 1161
traceable to Ph. Eur. Y0001132
traceable to USP 1708762

família API

valsartan

Certificado de análise (CofA)

current certificate can be downloaded

técnica(s)

HPLC: suitable
gas chromatography (GC): suitable

aplicação(ões)

pharmaceutical (small molecule)

formato

neat

temperatura de armazenamento

2-8°C

cadeia de caracteres SMILES

CCCCC(=O)N(Cc1ccc(cc1)-c2ccccc2-c3nnn[nH]3)[C@@H](C(C)C)C(O)=O

InChI

1S/C24H29N5O3/c1-4-5-10-21(30)29(22(16(2)3)24(31)32)15-17-11-13-18(14-12-17)19-8-6-7-9-20(19)23-25-27-28-26-23/h6-9,11-14,16,22H,4-5,10,15H2,1-3H3,(H,31,32)(H,25,26,27,28)/t22-/m0/s1

chave InChI

ACWBQPMHZXGDFX-QFIPXVFZSA-N

Informações sobre genes

human ... AGTR1(185)

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Descrição geral

Certified pharmaceutical secondary standards for application in quality control provide pharma laboratories and manufacturers with a convenient and cost-effective alternative to in-house working standards.
Certified pharmaceutical secondary standards for application in quality control provide pharma laboratories and manufacturers with a convenient and cost-effective alternative to pharmacopeia primary standards.
Valsartan is an orally active specific angiotensin II receptor blocker used for the treatment of hypertension.

Aplicação

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.
Valsartan may be used as a pharmaceutical reference standard for the determination of the analyte in pharmaceutical formulations by chromatography and spectrophotometry.

Nota de análise

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

Outras notas

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.

Nota de rodapé

To see an example of a Certificate of Analysis for this material enter LRAC2970 in the slot below. This is an example certificate only and may not be the lot that you receive.

Pictogramas

Health hazardExclamation mark

Palavra indicadora

Warning

Frases de perigo

Declarações de precaução

Classificações de perigo

Repr. 2 - STOT SE 3

Órgãos-alvo

Central nervous system

Código de classe de armazenamento

11 - Combustible Solids

Classe de risco de água (WGK)

WGK 3

Ponto de fulgor (°F)

Not applicable

Ponto de fulgor (°C)

Not applicable


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Stability indicating RP-HPLC method for determination of valsartan in pure and pharmaceutical formulation
Patro SK, et al.
Journal of Chemistry, 7(1), 246-252 (2010)
Stability-indicating UPLC method for determination of Valsartan and their degradation products in active pharmaceutical ingredient and pharmaceutical dosage forms
Krishnaiah Ch, et al.
Journal of Pharmaceutical and Biomedical Analysis, 53(3), 483-489 (2010)
Simultaneous spectrophotometric determination of valsartan and ezetimibe in pharmaceuticals
Ramachandran S, et al.
Tropical Journal of Pharmaceutical Research, 10(6), 809-815 (2011)
Simultaneous determination of valsartan and hydrochlorothiazide in tablets by RP-HPLC
Tian FD, et al.
Indian Journal of Pharmaceutical Sciences, 70(3), 372-372 (2008)
Genyang Cheng et al.
Nephrology (Carlton, Vic.), 20(2), 77-84 (2014-11-02)
The current standard treatment for IgA nephropathy relies on steroid and/or immunosuppressive therapy and angiotensin converting enzyme inhibitors (ACEI) or angiotensin receptor blocker (ARB). This study examines the benefits and safety of combining valsartan with clopidogrel and leflunomide as a

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