Stability of digoxin tablets collected from U.S. hospitals
Belson, J.J.; Juhl, Y.H.; Moyer, E.S.; Page, D.P.; Shroff, A.P.
American Journal of Hospital Pharmacy 38(12): 1903-1907
1981
ISSN/ISBN: 0002-9289 PMID: 7325170 Document Number: 169554
The stability of digoxin tablets that had been stored in hospitals across the USA was studied. All hospital pharmacies in the USA were informed in Feb. 1980 about the program, the reimbursement procedure, the sampling requirement and the process by which laboratory results would be distributed. Samples (92) representing 3 manufacturers and an adequate cross-section of the country, as well as typical dosage forms and packaging variations, were selected for laboratory analyses of content uniformity, strength, dissolution, identification and related fluorescing substances. Samples (85) met the current compendial standards and 7 samples failed the dissolution specifications. All 7 were manufactured before July 1975 when the USP dissolution requirements were changed. The digoxin products studied were not adversely affected by the variable stresses of the marketplace.