Chirality/Enantiomer Drug Separation

            Fig 1 Basic chiral structure¹Although the enantiomers of chiral drugs have the same chemical structure, most enantiomers show significant differences in biological activities such as pharmacology, toxicology, and pharmacokinetics. For chiral drugs, one isomer may be effective, while the other may be ineffective or even cause toxic side effects. In the pharmaceutical industry, the principle of compounds can be utilized to develop drugs with high efficacy and small side effects. Therefore, chiral separation and analysis play an important role in the identification of active isomers in the pharmaceutical industry.

Unlike other substances, the separation of chiral molecules poses a unique challenge because in a symmetrical environment, the chemical and physical properties of the enantiomers (except for the rotation of plane polarized light) are the same. With extensive experience in the development of chiral molecular separation methods, Alfa Chemistry is able to provide the most suitable separation methods for clients around the world in compliance with regulatory standards such as Good Laboratory Practice (GLP) and Good Manufacturing Practice (GMP). Alfa Chemistry provides economical and reliable purification solutions that allow you to obtain high purity compounds and comprehensive analytical reports. If you have any questions about the separation of chiral drug, please feel free to contact us.

The chiral analysis techniques we use include:

• High Performance Liquid Chromatography (HPLC)

• Gas Chromatography (GC)

• Supercritical Fluid Chromatography (SFC)

• Capillary Electrophoresis (CE)

• Nuclear Magnetic Resonance Spectroscopy (NMR)

Some guidance about chiral substances:

• FDA - Development of New Stereoisomeric Drugs

• The Therapeutic Products Programme of Health Canada - Guidance for Industry: Stereochemical Issues in Chiral Drug Development

• ICH - Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances

• European Medicines Agency - Investigation of chiral active substances

Alfa Chemistry's advantages:

Reference

• W.H. Brooks (2011) 'The Significance of Chirality in Drug Design and Development.' Current Topics in Medicinal Chemistry.' 11: 760-770.