Enantiomeric and Diastereomeric Excess Determination

Chiral analysis by enantiomeric and diastereomeric excess is essential in drug development because the compound’s enantiomers can have vastly different effects in the body. One enantiomer may provide the desired therapeutic effect, while the other could be inactive or even harmful. Accurate ee/de determination ensures that only the effective and safe enantiomer is developed and approved, improving drug efficacy and safety, and meeting regulatory requirements. Rilas offers enantiomeric and diastereomeric excess confirmation of starting materials, intermediates and final products.

Turnaround Time: 24 to 48 hours

ee/de Determination Process:

For each sample, using 1 mg or less racemic mixture , Rilas will perform a set of screening on >15 column chemistries (including the 7 we have the preparative versions of) from Chiral Technologies and Regis Technologies using a 5 –55% modifier (methanol, ethanol, 2 Propanol including 0.25% diethylamine) gradient in CO2 to determine best method column/modifier for chiral separation of the sample. Following the gradient screening, an optimized isocratic separation of the enantiomers is developed using the best modifier/column combination. This optimized condition is then used to determine of the ee/de of the sample of interest. The analytical separations are carried out by an Agilent 1260 Infinity II equipped with MS and UV/VIS detector.

Instrumentation:
Agilent 1260 Infinity II SFC/MS