Venkat Shinde

February 1, 2021
Difference between ICP-OES and ICP-MS

Difference between ICP-OES and ICP-MS

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

Assessment of Genotoxic Impurities

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

Data Integrity – General consideration and current understanding of the Pharmaceutical industry

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
Determination of Response factors of Impurities in Drugs by HPLC

Determination of Response factors of Impurities in Drugs by HPLC

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
Evaluation of Out of Trend (OOT) Results

Evaluation of Out of Trend (OOT) Results

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
NMR in Impurity Profiling for Pharmaceutical Products

Use of NMR in Impurity Profiling for Pharmaceutical Products

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

Importance of Mobile Phase Buffer Selection for HPLC to LC-MS

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
Importance of Corrective Action Preventive Action in Quality Management System

Importance of Corrective Action Preventive Action in Quality Management System

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
Drug-Excipient Compatibility Study

Drug-Excipient Compatibility Study

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 […]