RT Journal Article
SR Electronic
T1 Aluminum in Parenteral Products: Overview of Chemistry Concerns and Regulatory Actions
JF PDA Journal of Pharmaceutical Science and Technology
JO PDA J Pharm Sci Technol
FD Parenteral Drug Association (PDA)
SP 127
OP 131
VO 43
IS 3
A1 Charles P. Hoiberg
YR 1989
UL http://journal.pda.org/content/43/3/127.abstract
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.