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USP

Valsartan Related Compound B

United States Pharmacopeia (USP) Reference Standard

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Synonym(s):
N-(1-Oxobutyl)-N-[[2′-(2H-tetrazol-5-yl)[1,1′-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:
952652-79-8
Molecular Weight:
421.49
MDL number:
MFCD19689078
UNSPSC Code:
41116107
PubChem Substance ID:
329751481
NACRES:
NA.24

grade

pharmaceutical primary standard

API family

valsartan

manufacturer/tradename

USP

application(s)

pharmaceutical (small molecule)

format

neat

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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General description

This product is provided as delivered and specified by the issuing Pharmacopoeia. All information provided in support of this product, including SDS and any product information leaflets have been developed and issued under the Authority of the issuing Pharmacopoeia.For further information and support please go to the website of the issuing Pharmacopoeia.

Application

This USP reference standard is intended for use in specified quality tests and assays as specified in the USP compendia.
It is also used in the preparation of standard and system suitability solutions for the determination of organic impurities and performance tests of tablets and capsules, in accordance with the USP monographs, by liquid chromatography (LC) combined with UV detection, of the following:
  • Valsartan
  • Amlodipine and valsartan tablets
  • Valsartan and hydrochlorothiazide tablets
  • Amlodipine, valsartan, and hydrochlorothiazide tablets

In addition, it is used in the assay test of valsartan tablets by LC-UV following the USP monograph “Valsartan Tablets”.

Analysis Note

These products are for test and assay use only. They are not meant for administration to humans or animals and cannot be used to diagnose, treat, or cure diseases of any kind.  ​

Other Notes

Sales restrictions may apply.

Pictograms

Health hazardExclamation mark
GHS08,GHS07

Signal Word

Warning

Hazard Statements

H336,H361d

Hazard Classifications

Repr. 2 - STOT SE 3

Target Organs

Central nervous system

WGK

WGK 3

Flash Point(F)

Not applicable

Flash Point(C)

Not applicable

Certificates of Analysis (COA)

Search for Certificates of Analysis (COA) by entering the products Lot/Batch Number. Lot and Batch Numbers can be found on a product’s label following the words ‘Lot’ or ‘Batch’.

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Valsartan Tablets
USP43-NF38: United States Pharmacopeia and National Formulary
United States Pharmacopeia, 47(5), 4579-4579 (2017)
Valsartan and Hydrochlorothiazide Tablets
USP43-NF38: United States Pharmacopeia and National Formulary
United States Pharmacopeia, 37(4), 4580-4580 (2015)
Amlodipine, Valsartan, and Hydrochlorothiazide Tablets
USP43-NF38: United States Pharmacopeia and National Formulary
United States Pharmacopeia, 43(2), 279-279 (2017)
Valsartan
USP43-NF38: United States Pharmacopeia and National Formulary
United States Pharmacopeia, 33(3), 4577-4577 (2020)
Tablet formulation and development of a validated stability indicating hplc method for quantification of valsartan and hydrochlorthiazide combination.
Kharoaf, M. A. H. E. R., et al.
International Journal of Pharmacy and Pharmaceutical Sciences, 4.3, 284-290 (2012)
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