INTERNATIONAL CONFERENCE ON HARMONISATION GUIDELINES ON THE LIMITS OF GENOTOXIC IMPURITIES IN DRUG PRODUCT
Journal Title: International Research Journal of Pharmacy (IRJP) - Year 2012, Vol 3, Issue 4
Abstract
An impurity in a drug substance as defined by the International Conference on Harmonisation (ICH) guidelines is any component of the drug substance that is not the chemical entity defined as the drug substance. Similarly, an impurity in a drug product is any component of the drug product that is not the chemical entity defined as the drug substance or an excipient in the drug product. Genotoxic compounds have the potential to damage DNA at any level of exposure and that such damage may lead/contribute to tumour development. Thus for genotoxic carcinogens it is prudent to assume that there is no discernible threshold and that any level of exposure carries a risk. A threshold of toxicological concern (TTC) value of 1.5μg/day intake of a genotoxic impurity is considered to be associated with an acceptable risk (excess cancer risk of <1 in 100,000 over a lifetime) for most pharmaceuticals. From this threshold value, a permitted level in the active substance can be calculated based on the expected daily dose. Higher limits may be justified under certain conditions such as short-term exposure periods.
Authors and Affiliations
Sunil , Tarun Kumar , Kapil Thukral , Ajay Malik
Keywords
Related Articles
- EP ID EP145609
- DOI -
- Views 75
- Downloads 0
GENE KICKED MOUSE: KNOCK OUT MOUSE AND ITS APPLICATION
A knockout mouse is a laboratory mouse in which genes are inactivated, or "knocked out," an existing gene by replacing it or disrupting it with an artificial piece of DNA. The 2007 Nobel Prize in physiology or medicine i...
CHEMICAL ANALYSIS OF NIRGUNDI TAILA WITH SPECIAL REFERENCE TO PREPARATION IN DIFFERENT NUMBER OF DAYS
Sneha kalpana is a process where the active principles present in the drug are extracted with the Sneha (Ghee or Oil) during the pharmaceutical process. The method of preparation of different Taila kalpanas requires diff...
EFFECT OF DAILY FLUORIDE EXPOSURE ON FLUORIDE RELEASE BY HIGH STRENGTH GLASS IONOMER RESTORATIVE MATERIAL USED WITH ATRAUMATIC RESTORATIVE TECHNIQUE: AN IN VITRO STUDY
An in-vitro study was done to evaluate the effect of fluoride exposure, fluoride release and recharging capability by High strength Glass Ionomer restorative material used with Atraumatic restorative technique. 20 specim...
DIFFERENCE SPECTROPHOTOMETRIC ESTIMATION OF PRASUGREL HYDROCHLORIDE IN BULK AND TABLET DOSAGE FORM
A simple, precise and accurate difference spectroscopic method has been developed for the estimation of prasugrel hydrochloride in bulk and in pharmaceutical dosage form. The proposed method is based...
BIODEGRADABLE MICROSPHERES: A REVIEW
Microspheres are characteristically free flowing powders consisting of proteins or synthetic polymers having a particle size ranging from 1-1000 μm. The range of techniques for the preparation of microspheres offers a v...