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Key Documents

PHR1875

Supelco

Valsartan Related Compound A

Pharmaceutical Secondary Standard; Certified Reference Material

Synonym(s):

D-Valsartan, N-VALERYL-N-{[2’-(1HTETRAZOLE-5-YL)-BIPHENYL-4-YL]-METHYL}-D-VALINE(ent-Valsartan), (R)-N-Valeryl-N-([2′-(1H-tetrazole-5-yl)-biphenyl-4-yl]methyl)valine, N-(1-Oxopentyl)-N-[[2′-(2H-tetrazol-5-yl)[1,1′-biphenyl]-4-yl]methyl]-D-valine

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About This Item

Empirical Formula (Hill Notation):
C24H29N5O3
Molecular Weight:
435.52
MDL number:
UNSPSC Code:
41116107
NACRES:
NA.24

grade

certified reference material
pharmaceutical secondary standard

Quality Level

agency

traceable to USP 1708773

API family

valsartan

CofA

current certificate can be downloaded

packaging

pkg of 30 mg

application(s)

pharmaceutical small molecule

format

neat

storage temp.

2-8°C

SMILES string

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-/m1/s1

InChI key

ACWBQPMHZXGDFX-JOCHJYFZSA-N

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General description

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. Valsartan Related Compound A is an impurity of valsartan, an orally active specific angiotensin II receptor blocker or angiotensin-II antagonist, which is widely used in treating hypertension by lowering the blood pressure.

Application

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 tablet formulations, bulk and pharmaceutical dosage forms using reversed-phase high-performance liquid chromatography technique.

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 LRAB1041 in the Documents slot below. This is an example certificate only and may not be the lot that you receive.

pictograms

Health hazardExclamation mark

signalword

Warning

Hazard Classifications

Repr. 2 - STOT SE 3

target_organs

Central nervous system

Storage Class

11 - Combustible Solids

wgk_germany

WGK 3

flash_point_f

Not applicable

flash_point_c

Not applicable


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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)
Validated RP-HPLC method for the quantitative estimation of valsartan in bulk and pharmaceutical dosage forms
Thanusha G, et al.
International Journal of ChemTech Research, 2(2), 1194-1198 (2010)

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