Genotoxic Impurities and Its Risk Assessment in DrugCompounds by Tabrez Shaikh in DDIPIJ in Lupine Publishers.
Pharmaceutical drugs are always associated with some
unwanted chemicals along with active components. This unwanted
chemical compound is called an impurity. Thus, the common
definition of impurity is any substance coexisting with the drug
substance, such as starting material, reagents, catalyst, raw material
or intermediates arising during the synthesis or develop during
storage or shipment of the drug. Impurities provide no benefit to the
patient while it may have the potential to cause the adverse effect.
International Council for Harmonisation in its guideline ICH S2 (R1)
defines genotoxicity as “a broad term that refers to any deleterious
change in the genetic material, regardless of the mechanism by
which the change is induced.” While genotoxic impurities have been
defined as “Impurity that has been demonstrated to be genotoxic
in an appropriate genotoxicity test model, e.g., bacterial gene
mutation (Ames) test” . A potential genotoxic impurity (PGI)
has been defined as an “Impurity that shows a Structural alert for
genotoxicity but that has not been tested in an experimental test
model. Here potentially relates to genotoxicity, not to the presence
or absence of this impurity”. Genotoxic impurities impact the
genetic material by means of mutations through chromosomal
breaks, rearrangements, covalent binding or insertion into the DNA
during replication. These changes in the genetic material, caused
by the exposure to very low levels of a genotoxic chemical, can lead
to cancer. Thus, it is very important to identify genotoxic impurities
in drugs followed by monitoring and control at very low levels to
ensure safety to the public. To know more click on below link.
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