Uniformity of Dosage Units

Uniformity of Dosage Units
USP <905>

According to the USP “To ensure the consistency of dosage units, each unit in a batch should have a drug substance content within a narrow range around the label claim." The uniformity can be performed by one of two methods: Content Uniformity or Weight Variation. 

The Content uniformity method can be used for any dosage form, but the weight variation has a more narrow application. The Content Uniformity Method is based on the assay of the individual content in the drug substance(s) for a number of dosage units to determine whether the individual content falls within a set limit as determined by the number of units assayed. For example, a tablet with a small amount of active as the label claim (relative to the tablet weight) must be tested using the Content Uniformity method because the Weight Variation Method is not sensitive enough to the small amount of active to be representative.
USP <905>

Uniformity of Dosage Units

$ TBD

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