Genotoxic impurities Mechanism of Genotoxicity Genotoxicity Test

1. Genotoxic Impurities
Presented by :-
Varsha Jindaniya

2. Genotoxic
Impurities:-
Toxicity +Gene
=Toxicity in
Gene
Capability of the substance to damage the genetic
information of cell.Genotoxicity may cause the
change in structure , sequence, and the number of
gene which have direct and indirect effect on induction
of mutation , activation and deactivation of gene.
Effects like vital effect on body and abnormal gene.
Many changes may be permanently and heritable
which may affect the body and gene cell = pass to
future generation.

3. Genotoxic
Impurities
Toxic (damaging) to DNA.Substances that are
Genotoxic may bind directly to DNA or act indirectly
leading to DNA damage by affecting enzymes
involved in DNA replication, thereby causing
mutations which may or may not lead to cancer or
birth defects (inheritable damage).The mutations may
lead to a wide variety of diseases to cancer.

4. Genotoxic
Impurities

5. Genotoxic
Impurities

6. Genotoxic
Impurities
Mechanism ofGenotoxicity:
The damage to the genetic material is caused by the
interaction of theGenotoxic substance with the DNA
structure and sequence.TheseGenotoxic substance
interact at a specific site or location and change the
structure of DNA and in its mutation.

7. Genotoxic
Impurities
GenotoxicityTest:
To determine if an agent damage the genetic material
and cause cancer Drug +Gene = Damage (cross
linking, changes in structure of DNA, change in
mutation,Chromosomal changes , changes in
sequence etc).

8. Genotoxic
Impurities
SomeTypes of Impurities:
1. Impurities inOfficialArticles
2. Ordinary Impurities
3. OrganicVolatile Impurities
SomeTypes ofOrganic Impurities:
1. Synthesis Related Impurities
2. Formulation Related Impurities
3. Environment related
4. Formation of impurities on ageing

9. Genotoxic
Impurities
FunctionalGroup Related Impurities:
1. Ester hydrolysis
2. Hydrolysis
3. Oxidative degradation
4. Photolytic cleavage
5. Decarboxylatio

10. ThankYou