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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 drug product which isn’t the drug substance or an excipient. Quantification of impurities […]
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 […]
November 26, 2020
What is Out of-Specification Investigation and How to Proceed for it

What is Out of-Specification Investigation and How to Proceed for it?

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
Overview of Scale-Up and Post-Approval Changes (SUPAC)

Overview of Scale-Up and Post-Approval Changes (SUPAC)

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
Regulatory Requirement for Stability Study

Regulatory Requirement for Stability Study

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 […]