Expert: Michael Anisfeld - 3/12/2008

Question
We would like to complete bulk stability on our drug product (and/or intermediates) in small fibre drums that may easily be placed in a chamber rather than the larger fiber drums that would require a lot of space over the hold time.  Is this possible?  If so, can a warehouse bulk  storage study also be conducted the same way?  And should we be looking at the force and pressure within the drum sizes or is the temp and humidity vs head space more important?  
Thanks


Answer
If you drug product is an "active pharmaceutical ingredient" (API), then you can keep your stability sample in a small version of fibre drums (easily purchased with a volume of about 100mL).

If you are performing a stability study then it requires controlled temperatures according to ICH guidelines. If you are keeping reserve (retention) samples, warehouse storage is acceptable.