Abstract
The United States Pharmacopeia has proposed particulate matter limits for small volume parenterals using a HIAC particle size analyzer. This paper compares the results from a HIAC particle size analyzer, an automated image analyzer and the Pharmaceutical Manufacturers Association (PMA) membrane microscopic method. Ten lots of a dry powder antibiotic were used for the analysis. No correlation is readily evident among the different methods of particle size analysis. The HIAC results are generally lower than the PMA membrane microscopic method and those of the automated image analyzer.
- Received May 20, 1985.
- Accepted February 4, 1986.
- Copyright © Parenteral Drug Association. All rights reserved.
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