Degradation And Characterization Of Impurities Of New Active Pharmaceutical Ingredient Using Advance Analytical Techniques | 18768
Journal of Analytical & Bioanalytical Techniques
Like us on:
Our Group organises 3000+ Global Conferenceseries Events every year across USA, Europe & Asia with support from 1000 more scientific Societies and Publishes 700+ Open Access Journals which contains over 50000 eminent personalities, reputed scientists as editorial board members.
ne of the most important considerations in the drug discovery process is safety, not only of the drug itself, but also
impurities and degradation products. Impurities present in the API have to be identified to make sure no mutagenic or
toxic substances will be administered to patients. Drug product degradation profiles need to be established to guide stable
formulation and provide suitable drug shelf life assessment. Drug regulatory agencies also have requirements for characterization
of the impurity profile of a pharmaceutical. Structural characterization of impurities and degradation products in bulk drug
substances is an integral part of pharmaceutical product development. The analysis of these low level unknown impurities and
degradants can be very challenging. Various regulatory authorities like ICH, USFDA, Canadian Drug and Health Agency are
emphasizing on the purity requirements and the identification of impurities in Active Pharmaceutical Ingredient?s (API?s).
Impurity and degradant structure elucidation is a collaborative effort involving the analytical chemist, and /or formulation
as well as experts in degradation, mass spectrometry, and nuclear magnetic resonance. Identification of the degradation
sample set leads to understating of degradation mechanism. In present scenario, there is advancement in the conventional
instrumental techniques that aid in fast characterization of impurities and related substances/degradation products spectral
analysis and isolation, using new analytical techniques, like UPLC, LC-MS, GC-MS, SFC-MS, LC-NMR, CE-MS etc. The
conventional technique included separation and identification of impurities or related substances (RS) by suitable method.
Eventually they are isolated and followed by characterization using various spectroscopic techniques. The new advance concept
is their characterization by the use of advanced analytical techniques.
Sanjay Sharma has doctorate in Pharmaceutical Sciences and working as Associate Professor, Head of Department of Quality Assurance and Central Instrumtal
Lab-In Charge. He has 12 years professional experience of research, teaching and industrial. He has filed 3 patents and more than 30 international / national
research publications to his credit. He has been serving as a reviewer in many of reputed journals. He has been the guide for several PhD and PG students. His
current areas of research are analytical and bioanalytical method development, validation Degradation and Characterization of Impurities and handling conventional
and modern sophisticated instruments
Peer Reviewed Journals
Make the best use of Scientific Research and information from our 700 + peer reviewed, Open Access Journals