Transcription of Parenteral and Ophthalmic Drug Products …
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Parenteral and Ophthalmic Drug Products …
Parenteral and Ophthalmic drug Products leachables and Extractables working Group leachables in Parenteral and Ophthalmic drug Products (PODP) are those substances (both organic and inorganic) that are present in the drug product due to migration of substances from packaging systems (container closure systems, CCS). Such leachables are associated with the components or materials of construction of CCS that are in direct or indirect contact with the PODP. leachables typically correlate with extractables, which are those substances that can be extracted from the packaging system, and/or its associated components and materials of construction under experimental conditions, using appropriate solvents and extraction conditions.
Parenteral and Ophthalmic Drug Products Leachables and Extractables Working Group Leachables in parenteral and ophthalmic drug products (PODP) are those substances (both
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