Category: General article

ICH Guidelines are a global standard for developing and registering pharmaceuticals and medical products. They bring together regulatory authorities from different regions, including the United…

The standardization of excipients involves evaluating the excipient’s chemical and physical properties, impurity profile, and functionality. It involves all means of obtaining and guaranteeing appropriate…

PHYSICOCHEMICAL INTERACTIONS OF PHARMACEUTICAL EXCIPIENTS INTRODUCTION Physicochemical interactions of pharmaceutical excipients and active pharmaceutical ingredient lead to formation of molecular complexes, increase in rate of…

A pharmaceutical excipient is any ingredient in a drug product other than the active pharmaceutical ingredient (API) used to aid in the manufacturing process but…

Extraneous peaks are defined as Unwanted and unexpected peaks that appear in a chromatogram but are not related to the analyte being measured. Extraneous Peaks By the…

Pharmaceuticals Process Validation is the means of ensuring and providing documentary evidence that processes within their specified design parameters are capable of repeatedly andreliably producing…

Sampling and testing in process validation batches in pharmaceuticals refers to selecting a portion of a pharmaceutical product for a defined purpose, such as quality…

The action or process of disinfecting or purifying an area with the fumes of certain chemicals is fumigation method in medical and non-medical fields. Introduction…

Analyzing FDA form 483 data: Identifying trends and areas of concern in regulatory compliance in pharmaceuticals This study scrutinizes a dataset originating from the FDA’s…