August 6, 2020
Evaluation of Photodegradation Pathways

Evaluation of Photodegradation Pathways

Photostability study provides useful information about the handling and packing of drug substance and drug products. Most of the drug substances are light-sensitive hence during formulation […]
August 5, 2020

Drug Metabolite Impurities, Pathways & Analytical Techniques

Metabolites                     Metabolites are the intermediate products of metabolic reactions catalyzed by various enzymes that naturally occur within cells. The term metabolite is usually used for small molecules. Metabolites forms […]
August 4, 2020
Elemental Impurities in Pharmaceutical Products

Elemental Impurities in Pharmaceutical Products

Introduction  Elemental impurities in drug substance and drug products may arise from several sources; they may be residual catalysts that were added intentionally in the synthesis […]
August 3, 2020
Peptides and Probable Degradation Pathways

Peptides and Probable Degradation Pathways

Peptides These are naturally occurring biological molecules. peptides are made up of smaller molecular sequences of amino acids. When a molecule consists of 2 to 50 […]
August 1, 2020
Overview and Determination of Enantiomeric Impurities

Overview & Determination of Enantiomeric Impurities

Structures of a) ofloxacin (R-form) b) levofloxacin. Introduction Most of the drugs substance single enantiomer is active. In such cases the inactive enantiomer is considered as […]
July 31, 2020

Synthesis, Isolation, & Characterisation of Impurities

Synthesis: Synthesis of impurity with the predicted structure is tough and it may involve multistep synthesis. Hence for the synthesis of complex structures impurity, systematic and […]
July 30, 2020

Chemistry for The Formation of Nitrosamines

Introduction Nitrosamines, or more correctly N-nitrosamines, refer to any molecule containing the nitroso functional group. These molecules are of concern because nitrosamine impurities are probable human […]
July 29, 2020

Recent update on Nitrosamine Impurities by EP and US Pharmacopoeia

EMA issue the last date to comment on the analysis of Nitrosamine Impurities: The European Pharmacopoeia (Ph. Eur.) published its new general chapter on the analysis […]
July 28, 2020

The Role of Patents in the Pharmaceutical Industry

Introduction The pharmaceutical industry has a major role in the past decades in developing new technology in the field of product and process development. Further technology […]