Analytical method development and validation is one of the major steps in the process of API selection for generic drug development, proper characterization of APIs, sensitivity, precision, accuracy for quantification of the drug in a dosage form, linearity and assurance of inactive ingredient compatibility.
Purity, identification, assay, dissolution profile, disintegration time, LOD, water content and other analytical test methods are used to develop and validate data. A proper analytical approach ensures product quality and accelerates the development process by reducing development time.
Development of accurate methods is an essential element for the development of generic products which will ensure correct decisions being made from data for stability studies and formulation development as well.
GelEntroCeutics analysts will help you to select and use the most suitable analytical methods to control the quality of your products to the highest required standards.