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What is meant by the term “special procedure” as found under Content Uniformity in the official chapter?

April 26, 2017Chapter content meant official term uniformity

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What is meant by the term “special procedure” as found under Content Uniformity in the official chapter?

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Typically, the Content Uniformity determination is made on individual dosage units using the procedure found in the Assay. For certain products, a separate procedure is given in the monograph. Where that is the case, the monograph procedure would be considered a special procedure for content uniformity. Theophylline Extended–Release Capsules is an example of a monograph requiring a special procedure for content uniformity.