Dissolution Testing
What a definition is not
A definition is SPEQ’s plain-language decode of how a term is used in practice, cited to the documents that define it. It is a practitioner reference, not legal or regulatory advice, it does not replace the definition in the source, and where a regulator’s wording differs the regulator’s wording governs.
An in-vitro test measuring the rate and extent to which a drug substance is released from a solid oral (or other) dosage form into a specified aqueous medium under controlled agitation and temperature, used for routine quality control release testing, formulation development, and — where an in-vitro/in-vivo correlation is established — as a surrogate indicator of in-vivo bioavailability.
Dissolution apparatus, medium composition, agitation rate, and sampling time points are all specified per product and validated to be discriminating — sensitive enough to detect a manufacturing or formulation change that could affect bioavailability, but not so sensitive that it fails acceptable batches.
For immediate-release products with high solubility and permeability, a validated dissolution comparison can support a biowaiver in place of a full in-vivo bioequivalence study for certain post-approval changes, under the Biopharmaceutics Classification System framework.
Dissolution profile comparison, using similarity factors such as f2, is used to demonstrate equivalence between formulations, strengths, or before/after a manufacturing change, distinct from a single-time-point release specification.
- —Apparatus, medium, agitation, and time points are validated to be discriminating for the specific product.
- —Can support a biowaiver for certain changes under the Biopharmaceutics Classification System.
- —Profile comparison (e.g., f2 similarity factor) differs from a single-point release specification.
- —A key surrogate link between in-vitro quality control and in-vivo bioavailability.
USP <711>; USP <1092>; FDA Guidance for Industry: Dissolution Testing and Acceptance Criteria for Immediate-Release Solid Oral Dosage Forms
Frequently asked questions
What is Dissolution Testing?
An in-vitro test measuring the rate and extent to which a drug substance is released from a solid oral (or other) dosage form into a specified aqueous medium under controlled agitation and temperature, used for routine quality control release testing, formulation development, and — where an in-vitro/in-vivo correlation is established — as a surrogate indicator of in-vivo bioavailability.
Which regulations cover Dissolution Testing?
USP <711>; USP <1092>; FDA Guidance for Industry: Dissolution Testing and Acceptance Criteria for Immediate-Release Solid Oral Dosage Forms