Aluminum in parenteral products: overview of chemistry concerns and regulatory actions
Hoiberg, C.P.
Journal of Parenteral Science and Technology a Publication of the Parenteral Drug Association 43(3): 127-131
1989
ISSN/ISBN: 0279-7976 PMID: 2499669 Document Number: 342483
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.