There is no possibility of establishing quality of products without fixing the pharmacopeial drug dissolution test!

The quality of a drug product, such as a tablet and capsule, may be defined as the product’s ability to release the drug in humans in the expected amount and consistently. In technical terms, it is known as the drug release characteristics of the product. This characteristic is established at the manufacturing stage by conducting an in vitro test known as a drug dissolution/release test. The test is commonly conducted as recommended by regulatory agencies (such as FDA) and pharmacopeias (such as USP) using paddle and basket apparatuses. The quality assessment of most of the solid dosage forms, if not all, in particular, tablet and capsule products, is determined using this test.

The testers for this test, however, have never been validated for the intended purpose. Therefore, conclusions drawn from this test, hence the quality of the products, would be invalid and false. Use caution in accepting and/or making claims about the quality of products! (link)

Seek help for conducting a scientifically valid drug dissolution test and establishing the quality of the drug products.

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