Pharmacy Courses

Can I have Dissolution Results Higher than 100% of the Label Claim?

Yes, you can. BUT you need to find out why you are seeing such high numbers. Is it the drug product itself or an artifact of the testing procedure? 

Check Your Manufacturing Process

Consider the assay results and uniformity of dosage units. If these exceed 100%, there is a good chance that dissolution result will exceed 100%. Also check the drug product contain overage or not.

Calculation or Typographical Error

Calculation error or incorrect input values of standard weight, volume etc. could impact the dissolution results.

Dissolution Testing

Inadequate filtration or sampling procedure, placebo interferance could result falsely high dissolution values.

Early Spikes in Dissolution Profiles

Drug release greater than 100% at early time points that at the subsequent time points could be due to sampling of undissolved material.

Undissoved material could collect on the filter surface and dissolve resulting in higher measured concentrations.

A carry-over of undissolved material on the filter surface can also happen by using the same filter across all the time points of dissolution profile.

Dissolution results higher than 100% can occur consistently for a couple of units towards the end of dissolution or as random spikes at earlier dissolution points. If you see the results significantly above the 100% very often or random spikes you should investigate.

Read also: Comparative Dissolution Profile Guidelines

Resource Person: Pearl Pereira Nambiar

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