Acebutolol EP Impurity B

Stability of atenolol, acebutolol and propranolol in acidic environment depending on its diversified polarity
By Krzek, Jan; Kwiecien, Anna; Zylewski, Marek
From Pharmaceutical Development and Technology (2006), 11(4), 409-416
 

Acebutolol EP Impurity B is chemically N-[3-acetyl-4-[(2RS)-2-hydroxy-3-[(1-methylethyl)amino]propoxy]phenyl]acetamide (as per EP) N-{3-Acetyl-4-[2-hydroxy-3-(isopropylamino)propoxy]phenyl}acetamide (as per USP). It is also known as Diacetolol (EP) ; Acebutolol USP Related Compound B ; Diacetol ; Acetylacebutolol ; (±)-Diacetolol. Acebutolol EP Impurity B is supplied with detailed characterization data compliant with regulatory guideline. Acebutolol EP Impurity B can be used for the analytical method development, method validation (AMV), Quality Controlled (QC) application for Abbreviated New Drug Application (ANDA) or during commercial production of Acebutolol.

The product can be used as reference standards and further traceability against pharmacopeial standards (USP or EP) can be provided based on feasibility. SynZeal products are for analytical purpose only and not for human use.