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PHR1876

Valsartan Related Compound B

Name: Valsartan Related Compound B
Brand: SIAL

Pharmaceutical Secondary Standard; Certified Reference Material

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

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About This Item

Empirical Formula (Hill Notation):

C₂₃H₂₇N₅O₃

CAS Number:

952652-79-8

Molecular Weight:

421.49

UNSPSC Code:

41116107

NACRES:

NA.24

MDL number:

MFCD19689078

eCl@ss:

25140904

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Properties

Quality Segment

300

grade

certified reference material, pharmaceutical secondary standard

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

Description

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 and EP primary standards, where they are available.

Other Notes

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.

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Pictograms

GHS08,GHS07

Signal Word

Warning

Hazard Codes

H336,H361d

Precautionary Statements

P202 - P261 - P271 - P280 - P304 + P340 + P312 - P308 + P313

Hazard Classifications

Repr. 2 - STOT SE 3

Target Organs

Central nervous system

Storage Class

11 - Combustible Solids

WGK

WGK 3

Flash Point (°F)

Not applicable

Flash Point (°C)