Content Uniformity Test in Pharmaceutical Analysis

To ensure the consistency of dosage units, it is crucial that each unit in a batch contains a drug substance content that falls within a narrow range around the label claim. Dosage units are dosage forms that hold a single dose or a portion of a dose of the drug substance in each unit.

The consistency of dosage units can be shown through one of two methods: content uniformity and weight variation. This article discusses how content uniformity analysis is performed according to USP <905>.

1. Solid Dosage Forms

   • Assay 10 units individually using an appropriate analytical method

   • Calculate the acceptance value

2. Liquid Dosage Forms

   • Assay 10 units individually using an appropriate analytical method

   • Perform assay on the well-mixed material removed from an individual container in conditions of normal use

   • Report results as delivered dose

   • Calculate the acceptance value

Requirement to pass content uniformity:

• Acceptance value must be less than or equal to L1%

• If acceptance value > L1%, test additonal 20 units and calculate acceptance value. The requirements are met if the final acceptance value of the 30 dosage units is ≤ L1%, and no individual content of any dosage unit is less than [1 − (0.01)(L2)]M nor more than [1 + (0.01)(L2)]M

• The acceptance value is |M-X| + ks, with the terms defined in Table 2 below.

Reference: USP <905) Uniformity of Dosage Units

Read related article on Weight Variation in Pharmaceutical Analysis.

Feeling overwhelmed? Simplify the process with our content uniformity calculator. Quickly perform these calculations and make your life easier!

Content Uniformity Calculator Preview

Enter the % Label Claims for 10 dosage units, and the template will automatically calculate the acceptance value. It will also indicate whether the data passes or fails the test.