PT  - JOURNAL ARTICLE
AU  - Charles P. Hoiberg
TI  - Aluminum in Parenteral Products: Overview of Chemistry Concerns and Regulatory Actions
DP  - 1989 May 01
TA  - PDA Journal of Pharmaceutical Science and Technology
PG  - 127--131
VI  - 43
IP  - 3
4099  - http://journal.pda.org/content/43/3/127.short
4100  - http://journal.pda.org/content/43/3/127.full
SO  - PDA J Pharm Sci Technol1989 May 01; 43
AB  - In the May 23,1985 issue of the New England Journal of Medicine, Dr. Sedman et al. reported that many drug products that are routinely administered in parenteral therapy contain aluminum. From a manufacturing and control perspective, the Agency had obtained considerable information and data regarding (1) sources of aluminum contamination, (2) types of parenteral drug products containing aluminum, and (3) assay methodologies. Currently, in the review of drug applications in DSDDP, applicants are being requested to incorporate aluminum monitoring into their stability protocols and to implement, where possible, changes that will reduce aluminum contamination. Since acceptable analytical procedures are available and the aluminum contaminate is believed to be harmful to certain patient populations receiving parenteral therapy, the Agency is considering actions resulting in the imposition of regulatory controls.