Drug Excipient Compatibility Study During QbD

To perform Drug-Excipient Compatbility (DEC) study 4 types of samples are required to be preprared:

  1. API as such
  2. Excipient as such
  3. API + Excipient Physical Mixture
  4. API + Excipient Kneaded Mixture with approx 5% moisture

All these samples are packed in flint glass vial or amber color vial (if API is light sensitive) with and without sealing & exposed for a particular time period i.e. 1 Day, 3 Days, 7 Days, 14 Days and Maximum upto 28 Days at stressed conditions to accelerate the reaction e.g.

  • 60°C (to check the effect of heat)
  • 90%RH (to check the effect of moisture)
  • Option 1 Light Source of ICHQ1B (to check the effect of light)
  • 3%H2O2 (to check the effect of oxidation)

After incubation of all the samples at predefined storage conditions for predefined time periods samples are:

  • physically observed for any probable color or shade change
  • thermally analysed by DSC or TGA for any thermal based change
  • solid state characterised by pXRD or FTIR for any polymorphic form change
  • chemically analysed by HPLC for known Impurity or LC-MS or GC-MS for Unknown impurity evaluation.
Drug Excipients Compatibility Study

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Resource person: Dr. Shivang Chaudhary

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