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

Properties

• grade: certified reference material; pharmaceutical secondary standard
• Quality Level: 300
• 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
• 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: 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

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.

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.

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

Analysis Note

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

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.

Safety Information

• Storage Class: 11 - Combustible Solids
• wgk_germany: WGK 3
• flash_point_f: Not applicable
• flash_point_c: Not applicable