Abstract
It is widely recognized that the level of particulate matter in an injectable product is one measure of quality, directly reflecting the success with which the manufacturer applies good quality control. The current USP XXII1990 limits for particulate matter derived from knowledge that goes back to the 1970s but does not reflect the quality of the product available today. This presentation will discuss the purpose and background of proposed new limits intended to be adopted in the USP 23 revision cycle. The limits tests are structured in two stages for both Large-Volume and Small-Volume Injections, effectively employing an improved light obscuration method as a screening procedure. Product which fails this stage is then evaluated by a second stage, filtration and microscopic examination using a considerably improved procedure in which all of the container contents are sampled (or pooled to 25 mL) and the filter examined episcopically.
- Received March 11, 1993.
- Accepted May 19, 1993.
- 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.
