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Ezetimibe

SIAL/PHR1866 - Pharmaceutical Secondary Standard; Certified Reference Material

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

CAS Number: 163222-33-1
Empirical Formula (Hill Notation): C24H21F2NO3
Molecular Weight: 409.43
MDL Number: MFCD00937872
Linear Formula: C24H21F2NO3
Product Type: Chemical

Catalog Number PKG Qty. Price Quantity
45-PHR1866-1G 1 g
$257.00
1/EA
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agency traceable to USP 1269028
application(s) pharmaceutical
CofA current certificate can be downloaded
form powder
grade certified reference material
  pharmaceutical secondary standard
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
InChI key OLNTVTPDXPETLC-XPWALMASSA-N
packaging pkg of 1 g
Quality Level 300 
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
storage temp. 2-8°C
Analysis Note: These secondary standards offer multi-traceability to the USP, EP and BP 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
Footnote: 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.
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.
RIDADR NONH for all modes of transport
WGK Germany WGK 3
Flash Point(F) Not applicable
Flash Point(C) Not applicable
Storage Temp. 2-8°C
UNSPSC 12352200

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