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  • 1 Quinta Analytica
  • 1 Quinta Analytica
  • 1 Quinta Analytica
  • 1 Quinta Analytica

Analytical Research and Development

 

LC/MS and GC/MS methods for trace analysis

We are skilled in the development of analytical methods for determination of trace amounts of tracked impurities. For our customers we usually develop methods for assessment of toxic impurities at levels much below those demanded by corresponding regulatory authorities. Often we deal with systems where the target components are susceptible to decomposition or can react easily  with the active ingredient or sample matrix. Despite these challenges, we continue to succeed with the development of such methods. 

For this purpose we use LC/MS (HPLC 2695 Alliance(Waters)/LTQ (Thermo-Finnigan)) or GC/MS (7890A/5975C(Agilent Technologies)) technique. Routinely, we are able to achieve a sensitivity at ppm levels on both these systems which is usually sufficient for most pharmaceutical applications.

 When necessary, we benefit from cooperation with our bioanalytical department. There we may use several (mostly triple-quadrupole) LC/MS instruments in tandem offering a sensitivity in the order of units ppb.

For a highly sensitive detection in GC/MS we are using a chemical ionization source in combination with PTV injection.

Examples of trace analysis methods for some frequently tracked analytes:

  • determination of methyl iodide in Anastrozol (50 ppm) or in  Simvastatin intermediate (5 ppm)
  • determination of alkylsulfonates (methyl, ethyl, n-butyl and 2-propyl) in Doxazosin, Tamsulosin or Imatinib (30-1.5 ppm)
  • dimethylsulfate in  Ondansetron precursor (1 ppm)