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PHR1876

Supelco

Valsartan Related Compound B

Pharmaceutical Secondary Standard; Certified Reference Material

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Synonym(s):
N-(1-Oxobutyl)-N-[[2′-(2H-tetrazol-5-yl)[1,1′-biphenyl]-4-yl]methyl]-L-valine, N-butyryl-N-{[2′-(1H-tetrazole-5-yl)-biphenyl-4-yl]methyl}-L-valine, (S)-N-Butyryl-N-{[2′-(1-H-tetrazole-5-yl)-biphenyl-4-yl]methyl}valine
Empirical Formula (Hill Notation):
C23H27N5O3
CAS Number:
Molecular Weight:
421.49
MDL number:
NACRES:
NA.24

grade

certified reference material
pharmaceutical secondary standard

Quality Level

Agency

traceable to USP 1708784

API family

valsartan

CofA

current certificate can be downloaded

packaging

pkg of 30 mg

application(s)

pharmaceutical

format

neat

storage temp.

2-8°C

SMILES string

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

InChI

1S/C23H27N5O3/c1-4-7-20(29)28(21(15(2)3)23(30)31)14-16-10-12-17(13-11-16)18-8-5-6-9-19(18)22-24-26-27-25-22/h5-6,8-13,15,21H,4,7,14H2,1-3H3,(H,30,31)(H,24,25,26,27)/t21-/m0/s1

InChI key

OKAQHVJSXLGXET-NRFANRHFSA-N

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This Item
PHR1877PHR1875PHR2021
packaging

pkg of 30 mg

packaging

pkg of 30 mg

packaging

pkg of 30 mg

packaging

pkg of 20 mg

application(s)

pharmaceutical

application(s)

-

application(s)

-

application(s)

pharmaceutical

format

neat

format

-

format

neat

format

neat

storage temp.

2-8°C

storage temp.

2-8°C

storage temp.

2-8°C

storage temp.

2-8°C

Quality Level

300

Quality Level

300

Quality Level

300

Quality Level

300

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.

It is an impurity of the potent, highly selective, and orally active antagonist of the angiotensin II AT1-receptor, valsartan, used widely for the treatment of hypertension.

Application

This pharmaceutical secondary standard can also be used as follows:
  • Development of a reversed-phase high-performance liquid chromatographic (RP-HPLC) method for the determination of valsartan and its related impurities in pharmaceutical dosage forms
  • Impurity testing of valsartan, amlodipine besylate, and hydrochlorothiazide in their combined dosage form by a stability-indicating ultra-high performance liquid chromatography (UHPLC)
  • Simultaneous determination of amlodipine and valsartan in their combined dosage form, in the presence of their degradation products by a gradient reversed phase-liquid chromatographic (RP-LC) method
  • Separation and detection of nitrosamines and other related impurities in valsartan and losartan using supercritical fluid chromatography (SFC) in a single run
  • Development and validation of a UHPLC method for the estimation of sacubitril, valsartan, and their related impurities in their combined dosage form, following ICH Q2 (R1) guideline

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 LRAB1042 in the Documents 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

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


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Development and validation of a stability indicating UHPLC method for Sacubitril/Valsartan complex in the presence of impurities and degradation products
Prajapati P, et al.
Journal of Applied Pharmaceutical Science, 10, 097-107 (2020)
New stability indicating method for quantification of impurities in amlodipine and valsartan tablets by validated HPLC
Venkata Eranki RJ, et al.
International Scholarly Research Network, 2013 (2013)

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