Home Forums General Discussion Storing stability samples in their shipper boxes

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  • John O’Neill
    Moderator
    Post count: 67

    Posted for an industry colleague:
    We received thousands of units single dose nasal spray for stability. Can I store these samples in shipper cardboard boxes in chambers and remove part of the samples from the boxes and send for testing? I would like to know what industry practice is.

    John O’Neill
    Moderator
    Post count: 67

    If the shipper boxes don’t offer “protection” from humidity and temperature, there shouldn’t be a regulatory problem with storing the samples in them in the chambers and then sampling appropriate quantities from them. A couple of cautions with this:

    1.Prior to the start of the studies, put your justification in writing that storing the stability samples in the shipper cartons does not influence stability.
    2.Be careful storing cardboard containers at 5C and any chambers that maintain higher humidities. There’s a chance that you could get mold growth on the cardboard.

    What do our industry colleagues have to say about this situation?

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