21 CFR § 343.90 - Dissolution and drug release testing.
---
identifier: "/us/cfr/t21/s343.90"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 343.90 - Dissolution and drug release testing."
title_number: 21
title_name: "Food and Drugs"
section_number: "343.90"
section_name: "Dissolution and drug release testing."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "D"
subchapter_name: "DRUGS FOR HUMAN USE"
part_number: "343"
part_name: "INTERNAL ANALGESIC, ANTIPYRETIC, AND ANTIRHEUMATIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 321, 351, 352, 353, 355, 360, 371."
regulatory_source: "63 FR 56814, Oct. 23, 1998, unless otherwise noted."
cfr_part: "343"
---
# 343.90 Dissolution and drug release testing.
(a) [Reserved]
(b) *Aspirin capsules.* Aspirin capsules must meet the dissolution standard for aspirin capsules as contained in the United States Pharmacopeia (USP) 23 at page 132.
(c) *Aspirin delayed-release capsules and aspirin delayed-release tablets.* Aspirin delayed-release capsules and aspirin delayed-release tablets must meet the drug release standard for aspirin delayed-release capsules and aspirin delayed-release tablets as contained in USP 23 at pages 133 and 136 respectively.
(d) *Aspirin tablets.* Aspirin tablets must meet the dissolution standard for aspirin tablets as contained in USP 23 at page 134.
(e) *Aspirin, alumina, and magnesia tablets.* Aspirin in combination with alumina and magnesia in a tablet dosage form must meet the dissolution standard for aspirin, alumina, and magnesia tablets as contained in USP 23 at page 138.
(f) *Aspirin, alumina, and magnesium oxide tablets.* Aspirin in combination with alumina, and magnesium oxide in a tablet dosage form must meet the dissolution standard for aspirin, alumina, and magnesium tablets as contained in USP 23 at page 139.
(g) *Aspirin effervescent tablets for oral solution.* Aspirin effervescent tablets for oral solution must meet the dissolution standard for aspirin effervescent tablets for oral solution as contained in USP 23 at page 137.
(h) *Buffered aspirin tablets.* Buffered aspirin tablets must meet the dissolution standard for buffered aspirin tablets as contained in USP 23 at page 135.