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Forced Degradation or Stress Study

The stability of drug products or substance is a significant parameter which may be affecting the safety, purity, and potency. The Forced degradation studies or stability indicating methods of chromatography are used for the analysis of stability of samples in different pharmaceutical manufacturing.

These studies use to show the molecule chemical behavior which helps to develop formulation and packaging. Forced Degradation or stress study usually involves exposure of drug substances or product to humidity, heat, and light for solid-state studies, and also exposed to a different range of pH for solution-state studies the drug. This method is able to detect the loss of the analytes and consequently raise in degradation products.

Preferably, loss in active component or product and raise in degradation products analyzed by an analytical method. The degradation study should achieve 10 to 30 % degradation of your analyte and all degradations should be properly separated by the column and from the analyte.Various conditions for degradation are as follows.

  • Hydrolytic Degradation
  • Oxidative Degradation
  • Thermal Degradation
  • Photolytic Degradation

These are the studies of forced degradation that is used in the chromatographic analysis.

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Jose Hullgren (Laboratory Analist)

Hello to all readers, my name is Jose Hullgren, it is a pleasure to present you this website of my authorship, I am currently working as a laboratory analyst and for the last 10 years I have been working in the pharmaceutical industry. The main idea of this page is to provide relevant information in the field of the pharmaceutical industry above all. We also cover different areas of chemistry and sciences in general that we find interesting. Perfil Linkedin

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