Impurity Profiling - Liquid Vial Product

[Mouleyre]

When Carrying out impurity profiling of a new Drug Product vs RLD in the case of a Liquid vial product - would it be expected by the FDA that for this study the vials should be in inverted position or upright position - or maybe both positions?

[millerk8561]

I would think it would only need to be for the position that is recommended to the customer for storage (upright, I assume), assuming you're testing for formulation impurity and not container impurity (like with leachables analysis).

[Consumer Products Guy]

We had over the counter pharmaceuticals and had samples tilted so that the contents would be in contact with both container and closure.

[AnalyticalWisco]

It sounds like you're developing a generic, in which FDA's guidance on ANDAs: Stability Testing of DSs and DPs would be applicable. From the Q&A:

Q2: Can the Agency clarify expectations for the storage positions for products placed into the stability program?

A2: For primary batches of liquids, solutions, semi-solids, and suspensions, the product should be placed into an inverted (or horizontal) position and an upright (or vertical) position. For routine stability studies, the applicant should pick the worst case orientation for the study.

What's the route of administration? If its parenteral, you should also consider whether an extractable and leachables testing program is needed.