Related Substance and Chromatographic purity

Written by Akshatha / on 06/25/2010 / 2 Comments

Hi all

Am not very clear about the exact difference between related substances test and chromatogrphic purity test  for drug products........

I read in a book  that if a diluted standard is used for the impurity % calculation then it is called as chromatographic purity and when the standard concentration used is in line with that of sample  for impurity % calculation then it is related substances but i do not think it is applicable everywhen and it is correct.

 

please give your ideas

Regards

Akshatha

 

 

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Comments

  • tumuloori says:

    Dear Akshanta,
    Chromatographic purity test is qualitative test which will give individual area of impurity divided by total area gives % of that impurity.
    Related substance test is the test which will be done by qualitative method or quantitative method.Qualitative method is mentioned above.
    Quantitative method is area normalised method or internal standard method generally area normalised method rae followed.
    In area normalised method areas of standard,sample and concentration of standard , sample & purity of standard are considered,also RRT are also included.
    Regards
    T.Shashikanth
    09666690901

    June 5, 2011 at 6:35 PM | Permalink

  • Akshatha says:

    thanks a lot for the clarity provided by you..thanks a lot

    June 8, 2011 at 9:28 PM | Permalink

 

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