Serving Scientists Since 1994

Why Test?

Why Test?

From a manufacturing objective, the aim is to:

"Manufacture a dosage form in such a way that the active ingredient is released from the dosage form in a predicatable way and within a reasonable time in order for it to be absorbed by the body". Drugs also need to be released in the right area of the body - in the intestine instead of the stomach for example.

Most routine dissolution testing is used to confirm the statement above. 

When a dosage form is manufactured, there are a number of parameters which need to be checked:

  • That the active ingredient is released in the predicted way
  • That the manufactured batch is the same as previous batches and falls within the required levels.
  • That he product can be stored for the specified shelf life without deterioration
  • To ensure that the dosage form does not break up in transit
  • To confirm that the drug is stable over time.


The Dissolution Test is a very useful tool and the only standardised way to generate scientific data that enables comparison

In addition, standardised testing promotes globalisation and harmonisation and also acts as a referee to identify mis-branded or substandard products


Application of dissolution data

Testing the dosage form from production to the end of its shelf life produces data that

  • Confirms immediate quality control
  • Ensures that the drug is still pharmaceutically active throughout its shelf life
  • Includes stability testing within well defined and strict criteria for each drug
  • Validates the manufacturing process and confirms therapeutic equivalence


What is tested:

Dissolution testing is appropriate to a wide range of products:

  • ‘Traditional’ pharmaceuticals
  • Dietary supplements
  • Veterinary drugs
  • Other ‘remedies’


Next Page:  Theoretical Concepts of Dissolution