Physicochemical quality control of amiodarone tablets registered in Argentina (march-july 2022)
DOI:
https://doi.org/10.62035/rca.5.62Keywords:
amiodarone, tablets, sampling studiesAbstract
In order to address the monitoring of registered and marketed drug products and to be able to detect substandard medicines, the National Control Laboratory carried out a survey of the laboratories marketing oral Amiodarone 200 mg tablets in Argentina. Once identified, a representative sampling was carried out to perform identification, assessment and related substance tests on six drug products. The monograph of the Argentine Pharmacopoeia 7th edition (FA 7th) used was verified according to its guidelines. All drug products complied with the identification and assay of the active pharmaceutical ingredient. Regarding the testing of related substances, only one did not comply with the FA 7th specifications, but it did so with its own validated, registered, and authorized method by the regulatory authority in compliance with the guidelines of the World Health Organization in relation to the usefulness of the selection of test methods and specifications for the sampling objectives.
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Copyright (c) 2024 Ana Karina Saratsian, María del Pilar Álvarez, Eduardo Saint Martin, Verónica S. Llauró, Yanina I. Rodríguez
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