Leachable ve Extractable Studies
"Leachables Studies" are conducted to measure and evaluate the risks associated with possible leachable impurities from pharmaceutical container closures, process equipment and medical device packaging.
Plastic, polymer, rubber or glass material mixtures, printed surfaces and coatings used for pharmaceutical packaging should be selected according to the properties of the drugs.
Extractable and leachable substances; Identifying and measuring potentially harmful leachable impurities from pharmaceutical container closure systems, medical devices, medical device packaging, and process equipment and packaging is critical. It also causes many quality problems, especially health problems.
Extractable and leachable impurity information must be mandatory in the guidelines published by regulatory agencies of pharmacological substances such as FDA (U. S. Food and Drug Administration) and EMA (European Medicines Agency) and in applications made for packaging materials. must exist. Leachable is defined as the impurities that pass into the drug from the packaging material in direct contact with the pharmacological substance. Extractable is defined as organic or inorganic impurities obtained from the packaging using suitable solvents.
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