[Code of Federal Regulations]
[Title 21, Volume 5]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR343.90]

[Page 267]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF 
 
PART 343_INTERNAL ANALGESIC, ANTIPYRETIC, AND ANTIRHEUMATIC
DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE--Table of Contents
 
                      Subpart D_Testing Procedures
 
Sec. 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.