USP <711> Dissolution
Issued by United States Pharmacopeia (USP)
StandardAudit Scope
Specifies dissolution test apparatus (Apparatus 1 — basket, Apparatus 2 — paddle, etc.), test conditions, sampling, and acceptance criteria for solid oral dosage forms.
What It Proves
A solid oral dosage form (tablet, capsule) has been tested under USP-specified dissolution conditions and met release-rate acceptance criteria for the specific monograph or product specification.
What It Does Not Prove
USP <711> is a TEST METHOD, not a product quality determination. Passing <711> proves the dosage form releases active ingredient at the rate specified for that product type; it does NOT prove bioavailability, clinical efficacy, or absence of contaminants. ISO/IEC 17025 accreditation for dissolution is the third-party verification anchor.
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