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PHR1315

Supelco

Valsartan

Pharmaceutical Secondary Standard; Certified Reference Material

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Synonym(s):
Valsartan, N-(1-Oxopentyl)-N-[[2′-(2H-tetrazol-5-yl)[1,1′-biphenyl]-4-yl]methyl]-L-valine
Empirical Formula (Hill Notation):
C24H29N5O3
CAS Number:
Molecular Weight:
435.52
MDL number:
PubChem Substance ID:
NACRES:
NA.24

grade

certified reference material
pharmaceutical secondary standard

Quality Level

Agency

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

API family

valsartan

CofA

current certificate can be downloaded

technique(s)

HPLC: suitable
gas chromatography (GC): suitable

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-/m0/s1

InChI key

ACWBQPMHZXGDFX-QFIPXVFZSA-N

Gene Information

human ... AGTR1(185)

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1 of 4

This Item
1708762BP1161Y0001145
Valsartan Pharmaceutical Secondary Standard; Certified Reference Material

Supelco

PHR1315

Valsartan

Valsartan United States Pharmacopeia (USP) Reference Standard

USP

1708762

Valsartan

Valsartan British Pharmacopoeia (BP) Reference Standard

BP1161

Valsartan

Valsartan for system suitability European Pharmacopoeia (EP) Reference Standard

Y0001145

Valsartan for system suitability

technique(s)

HPLC: suitable, gas chromatography (GC): suitable

technique(s)

-

technique(s)

-

technique(s)

-

application(s)

pharmaceutical (small molecule)

application(s)

pharmaceutical (small molecule)

application(s)

pharmaceutical

application(s)

pharmaceutical (small molecule)

format

neat

format

neat

format

neat

format

neat

storage temp.

2-8°C

storage temp.

-

storage temp.

2-8°C

storage temp.

-

Quality Level

300

Quality Level

-

Quality Level

-

Quality Level

-

General description

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.

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 pharmaceutical formulations by chromatography and spectrophotometry.

Analysis Note

These secondary standards offer multi-traceability to the USP, EP (PhEur) 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 LRAC2970 in the slot below. This is an example certificate only and may not be the lot that you receive.

Pictograms

Exclamation markHealth hazard

Signal Word

Warning

Hazard Statements

Precautionary Statements

Hazard Classifications

Repr. 2 - STOT SE 3

Target Organs

Central nervous system

Storage Class Code

11 - Combustible Solids

WGK

WGK 3

Flash Point(F)

Not applicable

Flash Point(C)

Not applicable


Certificates of Analysis (COA)

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Valsartan Related Compound A United States Pharmacopeia (USP) Reference Standard

USP

1708773

Valsartan Related Compound A

LBQ657 ≥97% (HPLC)

Sigma-Aldrich

SML2064

LBQ657

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Simultaneous spectrophotometric determination of valsartan and ezetimibe in pharmaceuticals
Ramachandran S, et al.
Tropical Journal of Pharmaceutical Research, 10(6), 809-815 (2011)
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)
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)
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)
Henry R Black et al.
Drugs, 69(17), 2393-2414 (2009-11-17)
Valsartan is a nonpeptide angiotensin receptor antagonist that selectively blocks the binding of angiotensin II to the angiotensin II type 1 receptor. The efficacy, tolerability and safety of valsartan have been demonstrated in large-scale studies in hypertension, heart failure (HF)

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