Mixing 2 sources of API

Production
1

Can 2 sources of a single API be mixed together and used to manifacture a single lot of Drug product?

2

Yes please. You can use two sources of an API to manufacture a single lot of drug product, provided the following conditions are met.

  • The specification of API from both the sources is the same, including physical parameters such as particle size, crystal structure, and polymorphism etc.
  • The route of synthesis and impurity profile of API from both sources is the same, including processing steps.
  • Process validation of the drug product should be carried out using API from both sources.
  • Stability studies of the drug product are satisfactory.
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  1. Same Quality Standards :
  • Both API sources must meet the same pharmacopeial specifications (e.g., USP, EP, IP) and your internal quality specifications.
  1. Equivalence :
  • You must perform comparability studies (physico-chemical, impurity profile, polymorphism, etc.) to ensure equivalence.
  1. Regulatory Approval :
  • For regulated markets, you must:
    • Declare both API sources in your regulatory filings.
  1. Batch Traceability :
  • Maintain full traceability of both API sources and the quantities used.
  1. When It’s Not Recommended:
  • If regulatory approval is for only one source.
  • If polymorphic form, particle size, residual solvents, or impurity profiles differ significantly.
  • If there is risk of cross-contamination (e.g., from different manufacturing routes).