> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Dissolution Testing and Acceptance Criteria Guidance
- URL: https://www.fdaweb.com/dissolution-testing-and-acceptance-criteria-guidance/
- Published: 2018-08-08T12:00:00.000Z
- Updated: 2026-09-15T00:24:28.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5142061

FDA has issued a guidance, *Dissolution Testing and Acceptance Criteria for Immediate-Release Solid Oral Dosage Form Drug Products Containing High Solubility Drug Substances*, to give manufacturers recommendations for submission of NDAs, INDs, or ANDAs, as appropriate, for orally administered immediate-release drug products that contain highly soluble drug substances. The [document](https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM456594.pdf?ref=fdaweb.com) is intended to describe when a standard release test and criteria may be used in lieu of extensive method development and acceptance criteria-setting exercises.

FDA says this guidance finalizes one issued 8/2015, giving it a revised title to better reflect its focus on the solubility of the drug substance in the drug product.