Abstract
This paper traces the history of the development of Sterile Sodium Cefoxitin as a viable marketed product. The effects of a number of physical and chemical parameters on the stability of Sodium Cefoxitin are reviewed. The parameters discussed in detail include the stability advantages of sterile crystalline solid over amorphous freeze-dried product, the need for rubber stopper screening studies to eliminate interactions between Sodium Cefoxitin powder and rubber, and the profound effect of oxygen on the coloration rate of the product. Other developmental considerations such as stopper testing, solution stability and compatibility, assay methodology, development of customer use-tests, and processing techniques are discussed briefly as part of the scheme of product development. It was the intent of the authors to present the various phases of development and problem solving potentially associated with the development of an aseptically subdivided sterile solid for constitution. It is hoped that this information will prove useful to fellow members of the PDA in understanding problems that might arise with similar products.
- Received April 5, 1982.
- Accepted May 31, 1983.
- 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.