Abstract
A wide range of raw materials used for the production of large-volume parenterals were tested for their content of bacteria, molds, yeasts, and endotoxins. All raw materials were relatively free of microorganisms, although some mannitol samples contained relatively high amounts of endotoxin. The low endotoxin content of the other raw materials did not require the use of depth filters to remove endotoxins to prepare pyrogen-free infusion fluids.
Full text
PDF
Selected References
These references are in PubMed. This may not be the complete list of references from this article.
- Baggerman C., Brandsema C., Humer M., Visser J. A comparative study on the performance of asbestos-free depth-filters for removal of pyrogens from infusion fluids. J Pharm Pharmacol. 1981 Nov;33(11):685–691. doi: 10.1111/j.2042-7158.1981.tb13905.x. [DOI] [PubMed] [Google Scholar]
- Haskå G., Nystrand R. Determination of endotoxins in sugar with the Limulus test. Appl Environ Microbiol. 1979 Dec;38(6):1078–1080. doi: 10.1128/aem.38.6.1078-1080.1979. [DOI] [PMC free article] [PubMed] [Google Scholar]
- Sweadner K. J., Forte M., Nelsen L. L. Filtration removal of endotoxin (pyrogens) in solution in different states of aggregation. Appl Environ Microbiol. 1977 Oct;34(4):382–385. doi: 10.1128/aem.34.4.382-385.1977. [DOI] [PMC free article] [PubMed] [Google Scholar]