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PHR1866

Ezetimibe

Pharmaceutical Secondary Standard; Certified Reference Material

Synonym(s):

Ezetimibe, (3R,4S)-1-(4-Fluorophenyl)-3-[(S)-3-(4-fluorophenyl)-3-hydroxypropyl]-4-(4-hydroxyphenyl)azetidin-2-one

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About This Item

Empirical Formula (Hill Notation):
C24H21F2NO3
CAS Number:
163222-33-1
Molecular Weight:
409.43
UNSPSC Code:
41116107
NACRES:
NA.24
MDL number:
MFCD00937872

Key Documents

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Product Name

Ezetimibe, Pharmaceutical Secondary Standard; Certified Reference Material

InChI

1S/C24H21F2NO3/c25-17-5-1-15(2-6-17)22(29)14-13-21-23(16-3-11-20(28)12-4-16)27(24(21)30)19-9-7-18(26)8-10-19/h1-12,21-23,28-29H,13-14H2/t21-,22+,23-/m1/s1

SMILES string

FC(C=C1)=CC=C1N([C@H](C2=CC=C(O)C=C2)[C@H]3CC[C@H](O)C4=CC=C(F)C=C4)C3=O

InChI key

OLNTVTPDXPETLC-XPWALMASSA-N

grade

certified reference material
pharmaceutical secondary standard

agency

traceable to USP 1269028

API family

ezetimibe

form

powder

CofA

current certificate can be downloaded

packaging

pkg of 1 g

application(s)

pharmaceutical

storage temp.

2-8°C

Quality Level

300

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Analysis Note

These secondary standards offer multi-traceability to the USP and EP primary standards, where they are available.

Application

This pharmaceutical secondary standard can also be used as follows:
  • Development of two spectrophotometric methods to determine ezetimibe in bulk and pharmaceutical formulations
  • Separation and determination of ezetimibe and atorvastatin in their tablet dosage forms using capillary electrophoresis (CE)
  • Simultaneous estimation of valsartan and ezetimibe in their combined dosage tablet by a stability-indicating reversed-phase high-performance liquid chromatographic (RP-HPLC) method, validated as per ICH guidelines
  • RP-HPLC method-based multi analysis of rosuvastatin, telmisartan, ezetimibe, and atorvastatin in pharmaceutical dosage formulations
  • Quantitative analysis of ezetimibe and atorvastatin calcium in pharmaceutical formulations using spectrophotometry and TLC-densitometry-based methods

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.

Ezetimibe belongs to the class of 2-azetidione cholesterol absorption inhibitors. It selectively blocks the absorption of cholesterol from dietary and biliary sources and thereby prevents the transport of cholesterol through the intestinal wall.

Other Notes

To see an example of a Certificate of Analysis for this material enter LRAC1517 in the Documents slot below. This is an example certificate only and may not be the lot that you receive.

Storage Class

11 - Combustible Solids

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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Chemometric technique for the optimization of chromatographic system: Simultaneous HPLC determination of Rosuvastatin, Telmisartan, Ezetimibe and Atorvastatin used in combined cardiovascular therapy
Janardhanan VS, et al.
Arabian Journal of Chemistry, 9, S1378-S1387 (2016)
Stability-indicating HPLC method for the simultaneous determination of valsartan and ezetimibe in Pharmaceuticals
Ramachandran S, et al.
Tropical Journal of Pharmaceutical Research, 13, 809-817 (2014)
Spectrophotometric determination of ezetimibe
Lakshmi P, et al.
E-Journal of Chemistry, 7, 101-104 (2010)

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