PHR1876
Valsartan Related Compound B
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
About This Item
Recommended Products
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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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.
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
- 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
Footnote
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
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