Blog
January 14, 2021
Importance of Relative Response Factor in Impurities Quantification Impurities are the constituent in drug product which isn’t the drug substance or an excipient. Quantification of impurities […]
December 31, 2020
What is Out-of-Trend (OOT): The analytical results which are within the specification but not inside the expected trend related to initial result or anticipated result. OOT […]
December 23, 2020
Introduction: Nuclear Magnetic Resonance Spectrometry (NMR) is the best instrument technique in the pharmaceutical for the identification and characterization of impurities. NMR is also called as […]
December 11, 2020
Background: Considering the more complex products analytical scientist needs to develop the specific, accurate, robust stability indicating analytical method. At the time of method development analytical […]
December 9, 2020
Introduction: When the analytical results found out of specification or out of trend in that case systematic and detail investigation need to be done to find […]
December 3, 2020
What is drug-excipient compatibility? Drug-excipient compatibility study is very much important stage of formulation development of drug product in combination of excipients. It’s significant phase of […]
November 26, 2020
Background: FDA issued warning letter to the most of the drug substance and drug product manufacturer. During the inspection, FDA find out the fault, the way investigation of […]
November 21, 2020
Introduction: The development of increase in batch size from small scale to large scale is termed as scale-up. This process is required in-depth study and knowledge […]
November 17, 2020
Introduction: Pharmaceutical products shelf-life estimation by assessing through systematic stability study is regulatory requirement, during this review current regulatory requirements elaborated. The main aim of this […]