Developing validating dissolution procedures

The stability data package for submissions received after this date should follow the recommendations of this guidance.

It is recommended that submissions contain data from complete studies at the intermediate storage condition 30C 2C/65% .

This and other Guidance documents are available on the Therapeutic Products Directorate/Biologics and Genetic Therapies Directorate/ Marketed Health Products Directorate Website (s).

It should include the effect of temperatures (in 10C increments (e.g., 50C, 60C, etc.) above that for accelerated testing), humidity (e.g., 75% or greater) where appropriate, oxidation, and photolysis on the drug substance.

The testing should also evaluate the susceptibility of the drug substance to hydrolysis across a wide range of p H values when in solution or suspension.

Guidance documents are administrative instruments not having force of law and, as such, allow for flexibility in approach.