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Dissolution Testing

In the pharmaceutical industry, drug dissolution testing is routinely used to provide critical in vitro drug release information for both quality control purposes, i.e., to assess batch-to-batch consistency of solid oral dosage forms such as tablets, and drug development, i.e., to predict in vivo drug release profiles.

Both Apparatus 1 (Basket) and Apparatus 2 (Paddle) are used by Nelson Laboratories for dissolution testing.

Applicable Standards:

  • USP <711>

Study Outline:

In Stage S1 of dissolution testing, 6 tables are tested. The following parameters are chosen: apparatus, medium, volume of medium, rpm, and time of dissolution.

Each tablet is placed in the dissolution vessel and the analysis is continue according the chosen parameters at the time specified. At the end, an aliquot of the medium is removed from each vessel and filtered.

The filtrate is tested for Assay, using the appropriate method. The most common methods are HLPC or UV/Vis. If Stage S1 requirements are not met, additional 6 tablets are tested as Stage S2.

If Stage S2 requirements are not met, additional 12 tablets are tested as Stage S3.

The specifications of the respective stage are specified in the individual monograph according to the type of tablets (e.g. immediate release, extended release, delayed release, etc).

Testing Locations

 

If you have additional questions about Excipient Testing, or would like to consult with the experts at Nelson Labs, just send us a request or call our Fairfield, NJ facility  at +1 (973) 227-6882.