Chiral Analysis

Chiral separations and enantiomeric purity determination expertise for optical isomers of molecules using capillary electrophoresis, LC, GC and NMR

Chiral separations play a very important role in the understanding and development of optically pure drugs and chemicals.

The optical isomers of a number of chiral drugs exhibit marked differences in the pharmacological and toxicological activities and, therefore, chiral separation and analysis of racemic drugs in pharmaceutical industry plays a key role in the identification of the active isomer. The same holds true for the various flavourings. Often a particular optically active isomer or stereoisomer is the active flavour producing compound. Synthetic production of optically pure drugs and flavours involves considerable use of chiral chemicals; therefore, chiral separations and analysis are also critical for the production of these chemicals. 

Analysis of enantiomers of a chiral molecule pose a unique challenge as the chemical and physical properties of enantiomers (excepting the rotation of plane-polarized light and their affinity for other chiral molecules) are identical and therefore they are very difficult to separate.  

Enantiomers typically have the same physical and chemical properties but they generally exhibit differences in their affinity towards other chiral compounds. As a result of this differences appropriate analytical methodology can be developed and, where necessary, performed in compliance with regulatory standards such Good Laboratory Practice (GLP) and Good Manufacturing Practice (GMP).

Our chiral analysis experts provide characterization of enantiomers of chiral molecules and compounds, supporting your new chemical or product development, process optimization, scale-up and regulatory submissions. 

Our labs also provide Chiral Method Development/Optimisation.

Chiral Analytical Instrumentation 

Intertek's analytical laboratories are equipped with a range of instrumentation for chiral separation and structure confirmation. 

We undertake the following techniques:

  • Chiral analysis by liquid chromatography (LC) and gas chromatography (GC)
    The laboratories use a range of chiral columns (LC, GC) which can be molecule specific. Method development for particular chiral molecule measurements is available.
  • Chiral analysis by capillary electrophoresis (CE)
    Capillary Electrophoresis (CE) uses Cyclodextrins (CDs) and substituted CDs as the most common chiral selectors. The method is usually rapid.
  • Chiral analysis by Nuclear Magnetic Resonance Spectroscopy (NMR)
    NMR uses chirally pure complexing reagents or chirally pure Lanthanide shift reagents.
GMP and GLP Chiral Analysis for Regulatory Requirements

We provide regulatory-driven, analysis in support of your regulatory programs such as new chemical notification studies or pharmaceutical development requirements. Our laboratories can perform analysis compliant with Good Laboratory Practice (GLP)and Good Manufacturing Practice (GMP).

    With over 20 years’ experience in chiral analysis determination of chiral purity and enantiomeric excess, Intertek supports a diverse range of pharmaceutical, biopharmaceutical and fine chemical development and notification.  From our network of global laboratories, our teams of scientists deploy their expertise to gain accurate and comprehensive data about your chiral molecules.

    Related Services:
    Fine and Speciality Chemicals Analysis
    NMR Analysis for Pharmaceuticals
    GLP and GCP Bioanalytical Services 

       

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