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This document provides the definition, identification tests, assay, and dissolution test methods for zonisamide capsules. It defines zonisamide capsules as containing between 90-110% of the labeled amount of zonisamide. The identification tests include a retention time test by HPLC and an IR spectroscopy test. The assay uses HPLC to determine the zonisamide content. The dissolution test provides two procedures using either spectrophotometry or HPLC to test the dissolution of zonisamide from the capsules.
- Author
- Nguyen Van Thao
- Language
- EN