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Analytical Requirements for Oral Solutions

Analytical requirements for the NDA submission of an oral solution to the FDA are very similar to those requirements for any new drug product. The analytical methods that are used for the testing of an oral solution at the NDA stage of development should be fully validated per the ICH guidelines, Q2A and Q2B, now ICHQ2(R1) . A new drug substance specification should be set based on ICH Q6A ICHQ6A .

Very generally, the following tests are needed for release specifications;

  • Identification
  • pH
  • Content Uniformity
  • Assay
  • Related Substances
  • Residual Solvents
  • Microbial limits
  • Fill Volume

Specific gravity and viscosity may also be needed depending on the properties of the oral solution.

Certificates of analysis for three lots manufactured with the proposed commercial process should be provided.

Stability indicating methods and specifications are required, with validation. Real-time stability data to support the shelf-life on three batches that are manufactured at least one tenth of the proposed commercial batch size and with the commercial process. A minimum of 12 months of real-time data are required. Shorter time periods can be provided, but the expiration date will be decided based on the length of the data submitted.