Genotoxic Impurities and Its Risk Assessment in Drug Compounds
Journal Title: Drug Designing & Intellectual Properties International Journal - Year 2018, Vol 2, Issue 4
Abstract
The present work is based on a assess analysis of the literature in order to define the genotoxic impurities present in the drug substances and drug products. Starting from the definition of genotoxic impurities, sources of genotoxic impurities, their generation and classification based on their toxicity. The article also explains the various regulatory guidelines to control the genotoxic impurities in drug substances. Isolation, qualification of impurity and its identification along with quantification by the various analytical methods is also described in this review article. 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” [1]. 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 [2,3].
Authors and Affiliations
Amit Gosar, Hussain Sayyed, Tabrez Shaikh
Keywords
Related Articles
- EP ID EP588786
- DOI 10.32474/DDIPIJ.2018.02.000143
- Views 154
- Downloads 0
Ionic Liquid Technology: A Budding Innovative Podium for the Pharmaceutical Industry
Ionic liquids considered to be a reasonably current magical chemical due their unique properties, have a large variety of applications in all areas of the chemical and pharmaceutical industries. The areas of application...
Gut Micro biome, Multiple Sclerosis, and Cancer
Thanks to their influence on the owner’s gut micro biome, dogs may be beneficial in reducing cardiovascular, diabetes, multiple sclerosis and cancer risk by providing a non-human form of social support and increasing phy...
Current Challenges and Obstacles to Drug Development for Chagas Disease
Chagas disease is a protozoan infection which was first identified more than one hundred years ago. But even now, drugs to treat the latent and chronic phases of the disease are not available. The success of a drug desig...
Preparatory Preparations for the Study of Drug Therapies for Emergency Diseases
In the US, more than 400,000 medical treatments are carried out each year to eliminate intestinal adhesion. The economic loss from these medical treatments is estimated to be about $1.2 billion. This economic loss has be...
Ethnomedicobotany: People Health through Wild Plant Resources
Ethnomedicine is an area of research that deals with medicines derived from plants, animals and minerals etc. and used in the treatment of different human and veterinary ailments. Ethnomedicines includes indigenous belie...