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What is Uniformity Assurance testing?

Uniformity assurance covers a broad range of analytical tests that provide batch-batch consistency confidence. Some examples of the tests typically performed are:

  • Uniformity of weight and weight variance 
  • Uniformity of content 

These tests are designed to ensure that every tablet and capsule contains the same amount of drug substance with a defined allowed variation within a batch. 

Why do we do it?
Uniformity of content studies are an essential step in the quality control of tablets or capsules as defined in all major pharmacopoeias. It ensures that all tablets are within a tolerance of their average weight giving intra and inter batch uniformity data.

How can we help assure compliance?
The content uniformity can be calculated with various methods depending on the pharmacopoeia and product presentation, typically using content uniformity or mass variation. For individual dosage units the EP states that content uniformity is “based on the assay of the individual contents of the active substance(s)”. Mass variation can be applied as per the EP for the following:

  • Single doses in containers or soft capsules
  • Solids (powders, granules and sterile solids) that contain no active or in-active added substances
  • Solid dosage forms containing 25mg or more of an active substance comprising of 25 percent or more, by mass, of the average dosage unit. 

Firstly an assay is performed on the active substance to calculate the concentration per dosage unit. Following that accurately weighing 10 tablets/capsules in accordance with the pharmacopoeial methods. From this weight you can calculate the mass of the active substance using the label claim and an acceptance value can be derived from a combination of active substance weight and concentration from the assay.

Honeyman have a broad range of experience in performing solid-dosage form QC release testing. Our expert analytical chemists are specialists in content uniformity, disintegration, dissolution and assay. 

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