Home Forums General Discussion Is container closure a stability-indicating test?

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  • John O’Neill
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    An interesting question. Not in the traditional sense, because it does not distinguish the active ingredient from any degradation products and make a reliable estimate of the quantity of any degradate. FDA’s Expiration Dating and Stability Testing for Human Drug Products states “Testing procedures must include a stability indicating test which will distinguish the active ingredient from any degradation products and be able to make a reliable estimate of the quantity of any degradate. The stability indicating test does not have to be the assay method used to determine product strength.

    One might argue that the CCIT is for physical failures of packaging or the sealing process and is separate from degradation of the product, but further examination of Guidances reveals that the following viewpoint exists: “For products labeled as sterile, we consider sterility to be a stability characteristic. If you currently perform sterility testing as a stability-indicating test as part of a stability protocol, you may continue to do so.” Making the leap that CCIT can “cover” sterility testing, CCIT seems to be drawn into an expanded definition of a Stability-Indicating Test. Your regulatory colleagues should assess the risk of declaring CCIT in, or out, as stability indicating for your product before you proceed in either direction.

    What do the rest of you think; Is CCIT Stability indicating, or not stability indicating?

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