Atropine EP Impurity E

Impurity profiling of atropine sulfate by microemulsion electrokinetic chromatography
Yaser Bitar, Ulrike Holzgrabe
Journal of Pharmaceutical and Biomedical Analysis 44 (2007) 623–633
 
Utilization of an Electrochemiluminescence Sensor for Atropine Determination in Complex Matrices
Kelly Brown,† Moira McMenemy,† Matthew Palmer,† Matthew J. Baker,† David W. Robinson,‡ Pamela Allan,† and Lynn Dennany
Anal. Chem. 2019, 91, 19, 12369–12376
 
Development and Application of a Validated UHPLC Method for the Determination of Atropine and Its Major Impurities in Antidote Treatment Nerve Agent Auto-Injectors (ATNAA) Stored in the Strategic National Stockpiles
Cheng H. Yen1, Adil Mohammad2, Miah Schneider1, Salwa K. Poole1, Bryan Lowry2, Brenda W. Mc Curdy1, Patrick J. Faustino2, Saeed R. Khan
Pharmacology & Pharmacy 08(01):15-31

Atropine EP Impurity E is chemically (1S,3R,5S,6RS)-6-hydroxy-8-methyl-8-azabicyclo[3.2.1]oct-3-yl (2S)-3-hydroxy-2-phenylpropanoate (as per EP) ; (1S,3R,5S)-6-Hydroxy-8-methyl-8-azabicyclo[3.2.1]oct-3-yl (S)-3-hydroxy-2-phenylpropanoate (as per USP). It is also known as 7-Hydroxyhyoscyamine (EP & USP). Atropine EP Impurity E is supplied with detailed characterization data compliant with regulatory guideline. Atropine EP Impurity E 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 Atropine.

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.