Impurity Profile: A description of the identified and unidentified impurities
present in a new drug substance.
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Potential Impurity: An impurity
that theoretically can arise during manufacture or storage. It may or may not
actually appear in the new drug substance.
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Enantiomeric Impurity: A compound with the same molecular formula as the drug
substance that differs in the spatial arrangement of atoms within the
molecule and is a non-superimposable mirror image.
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Identified Impurity: An impurity for
which a structural characterisation has been achieved.
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Unidentified Impurity: An impurity for which a structural characterisation has
not been achieved and that is defined solely by qualitative analytical
properties (e.g., chromatographic retention time).
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Specified Impurity: An impurity
that is individually listed and limited with a specific acceptance criterion
in the new drug substance specification. A specified impurity can be either
identified or unidentified.
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Unspecified impurity: An impurity that is limited by a general acceptance
criterion, but not individually listed with its own specific acceptance
criterion, in the new drug substance specification.
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Wednesday, 25 September 2019
Impurities – Definitions
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Very simply explained keep the good work
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