Phimtech B.V.

    Country:  Netherlands

    Business Type: Lab/Research institutions

  • Mr.Alexander Gaas
    Tel: +31-681481083

  • Mobile:
  • Tel:+31-681481083
  • Fax:+31-681481083
  • Province/state:Amsterdam
  • City:Amsterdam
  • Street:1082LT, AJ Ernstraat 162, Amsterdam, The Netherlands
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  • The purity is the most important issue in API and takes decisive part in licensing process.
    Even small amounts of unwanted chemicals may change the efficacy and moreover the safety of drug product. The International Conference on Harmonization (ICH) has formulated a workable guideline regarding the control of impurities.
    The current tendency of regulatory authorities is to be more rigid to requirements concerned API purity.
    The control and qualification of the impurities is non routine process of acquiring
    and evaluating data, thus, revealing the need and scope of impurity profiling of drugs in pharmaceutical research.
    Dedicated reference standards for impurities can help in the development and validation of analytical methods for impurity control, and are also used in the routine analysis of drug products. <  Click for details>>

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