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Content Uniformity Testing is useful for assessing the consistency of:
- Powder blends before filling or compressing
- Semi-solid and liquid bulk batches before filling
- Filling during manufacturing (such as powders into capsules or liquids into vials or bottles)
- Active content within individual units post-manufacturing (such as individual tablets after compression)
Content uniformity testing involves using a content/potency assay to determine the content of active material contained in multiple different samples collected throughout the batch.
Examples of sample sets that may be collected for content uniformity determinations are:
- Tablets from the beginning, middle and end of a compression run
- Aliquots of bulk material taken from the top, middle and bottom of a vessel before filling
- Randomly selected bottles filled with a liquid taken out of a packaged case
- Randomly selected capsules taken from a single bottle representing 10% of the number of capsules filled into the bottle
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