Ezetimibe Impurity 53

Ezetimibe Impurity 53 (CAS 272778-12-8) is supplied by ImpurityLab as a process impurity standard, covering impurities that are neither pharmacopoeially lettered nor degradation products of the parent substance. Catalogue number C4X-109853. It is related to Ezetimibe.

Parent drug substance. Ezetimibe. Browse the full Ezetimibe impurity and related compound standards held by ImpurityLab.

The material is issued against molecular formula C39H46F2N2O5Si2, molecular weight 716.96 g mol⁻¹, physical form described as white to off-white solid.

Structural notation: [Si](C)(C)(C)O[C@H](C1C=CC(=CC=1)F)CC[C@H]([C@@H](C1C=CC(=CC=1)O[Si](C)(C)C)NC1C=CC(=CC=1)F)C(N1C(=O)OC[C@@H]1C1C=CC=CC=1)=O

Process impurities are controlled through the ICH Q3A reporting, identification and qualification thresholds, or through the equivalent thresholds in ICH Q3B for the drug product. The limits depend on the maximum daily dose of the product rather than on the impurity itself.

Storage. Store at 2-8 °C. Allow the container to reach room temperature before opening so that moisture does not condense onto the material. Record the date of first opening on the label.

Pack sizes. 10 mg. Non-standard quantities are quoted on request, normally within two working days.

Documentation. Each lot is released with a certificate of analysis that states the assay method, the water content and the form as supplied. The safety data sheet is available with the same lot number. Quote catalogue number C4X-109853 when requesting either document.