Contamination of 0.2-micrometer infusion filters by N,N-dimethylacrylamide
Joanna Gasch1, Reinhard Oertel, Claudia S Leopold
1Klinik-Apotheke, Universitätsklinikum Carl Gustav Carus der Technischen Universität Dresden, 01307 Dresden, Germany. joanna@hw-arts.de
Purpose:
Infusion filters, 0.2 mum, are commonly used in intensive care units as in-line filters to minimize particle and microbiological burden on patients. These filters usually contain either a positively charged or an uncharged membrane. The aim of the present study was to identify and to quantify an additive causing an unexpected maximum at 234.5 nm in the ultraviolet spectrum of a filtered drug solution using a filter.
Materials And Methods:
For identification and quantification of the substance, water for injection was used as eluent. Measurements were done by mass spectrometry and ultraviolet spectroscopy.
Results:
The unexpected additive in the filter was found to be N,N-dimethylacrylamide. The eluate of 2 filter batches had a mean N,N-dimethylacrylamide concentration of 3.9 and 2.5 microg/mL, respectively. Further investigations showed that after infusion breaks of different duration, the N,N-dimethylacrylamide concentration at the beginning of the next infusion cycle reaches a higher level than that at the end of the preceding infusion cycle.
Conclusions:
The type of filter examined in this study is primarily used in premature infants, newborns, and infants. These patients are vulnerable to neurotoxic substances having a long-term effect. Therefore, N,N-dimethylacrylamide should be completely removed from the final filter product.
Insights
An unexpected additive, N,N-dimethylacrylamide, was found in 0.2 µm infusion filters used in intensive care. This neurotoxic substance, harmful to infants, should be removed from filters.
Area of Science:
- Pharmaceutical analysis
- Medical device materials science
Background:
- 0.2 µm infusion filters are standard in ICUs to reduce particle and microbial load.
- Filters utilize positively charged or uncharged membranes.
Purpose of the Study:
- To identify and quantify an unknown additive causing a UV spectrum peak at 234.5 nm in filtered drug solutions.
- Investigate the source of the additive in specific infusion filters.
Main Methods:
- Utilized water for injection as an eluent for substance extraction.
- Employed mass spectrometry and ultraviolet spectroscopy for identification and quantification.
Main Results:
- Identified N,N-dimethylacrylamide as the unexpected additive in the filter.
- Quantified mean N,N-dimethylacrylamide concentrations of 3.9 and 2.5 µg/mL in two filter batches.
- Observed increasing N,N-dimethylacrylamide levels after infusion breaks.
Conclusions:
- The filter type is used in vulnerable infant populations (premature, newborns, infants).
- N,N-dimethylacrylamide poses a potential neurotoxic risk with long-term effects in infants.
- Complete removal of N,N-dimethylacrylamide from the final filter product is recommended.
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