Abstract
From January 1980 to October 1983, the Food and Drug Administration (FDA) examined 2526 samples, including 333 different drug products, by the limulus amebocyte lysate (LAL) method. Of the drug products tested, 99 showed no product inhibition and 236 required some dilution to overcome inhibition. Compatible endpoints of 20 drug products varied by more than one twofold dilution; 14 were inhibitory at the maximum valid dilution and unsuitable for this analysis. Of the total samples tested, 77 (3.05%) contained various amounts of endotoxin and 15 of these failed the proposed FDA limit (K/M). The LAL test was found to be extremely useful for detecting and quantifying bacterial endotoxins in a wide variety of parenteral products.
- Received May 31, 1984.
- Accepted September 10, 1984.
- Copyright © Parenteral Drug Association. All rights reserved.
PDA members receive access to all articles published in the current year and previous volume year. Institutional subscribers received access to all content. Log in below to receive access to this article if you are either of these.
If you are neither or you are a PDA member trying to access an article outside of your membership license, then you must purchase access to this article (below). If you do not have a username or password for JPST, you will be required to create an account prior to purchasing.
Full issue PDFs are for PDA members only.
Note to pda.org users
The PDA and PDA bookstore websites (www.pda.org and www.pda.org/bookstore) are separate websites from the PDA JPST website. When you first join PDA, your initial UserID and Password are sent to HighWirePress to create your PDA JPST account. Subsequent UserrID and Password changes required at the PDA websites will not pass on to PDA JPST and vice versa. If you forget your PDA JPST UserID and/or Password, you can request help to retrieve UserID and reset Password below.
Log in using your username and password
Log in through your institution
Purchase access
patientACCESS
In This Issue
Jump to section
Related Articles
Cited By...
- No citing articles found.