Working standard selection criteria

Please specify the working standard selection criteria during qualification or working standard of API and intermediates. for example; selection WS from source not less than 99% of the Assay like this. Is there any specific guideline please mention. Auditors asking this question to specify in SOP.

For selection & qualification of working standard please consider following criteria,

  • Assay closer to 100%
  • Impurities (Known & unknown) at a minimum level
  • Well-characterized molecule
  • API source batch is traceable with its COA and impurity profile
  • Minimum available shelf life of source API batch (not to select older batch of API)
    Preferably at least 75-80% of shelf life should be available.
  • Ease of availability and sufficient quantity

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