Blog
February 1, 2021
Background: Elemental impurities affect drug effectiveness, it doesn’t have any therapeutic benefit but has a toxic effect on the patients. Elemental impurities may be present in […]
January 27, 2021
The US Food and Drug Administration (FDA) finalized International Conference on Harmonization (ICH) guidance on DNA-reactive substances that could potentially cause damage when present at low […]
January 25, 2021
Introduction Data integrity is an important and current top issue for many regulatory authorities these days as many pharmaceutical industries found multiple problems due to poor […]
January 14, 2021
Importance of Relative Response Factor in Impurities Quantification Impurities are the constituent in a drug product that isn’t the drug substance or an excipient. Quantification of […]
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 […]