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Introduction  This document presents a discussion of the characteristics for consideration during the validation of the analytical procedures included as part of registration applications submitted within the EC, Japan and USA. This document does not necessarily seek to cover the testing that may be required for registration in, or export to, other areas of the world. Furthermore, this text presentation serves as a collection of terms, and their definitions, and is not intended to provide direction on how to accomplish validation. These terms and definitions are meant to bridge the differences that often exist between various compendia and regulators of the EC, Japan and USA.  The objective of validation of an analytical procedure is to demonstrate that it is suitable for its intended purpose. A tabular summation of the characteristics applicable to identification, control of impurities and assay procedures is included. Other analytical procedures may be considered i...

Introduction The molecular spectroscopy is the study of the interaction of electromagnetic waves and matter. The scattering of sun’s rays by raindrops to produce a rainbow and appearance of a colorful spectrum when a narrow beam of sunlight is passed through a triangular glass prism are the simple examples where white light is separated into the visible spectrum of primary colors. This visible light is merely a part of the whole spectrum of electromagnetic radiation, extending from the radio waves to cosmic rays. All these apparently different forms of electromagnetic radiations travel at the same velocity but characteristically differ from each other in terms of frequencies and wavelength. Absorption of Different Electromagnetic radiations  In absorption spectroscopy, though the mechanism of absorption of energy is different in the ultraviolet, infrared and nuclear magnetic resonance regions, the fundamental process is the absorption of a discrete amount of energy. The...

1.      Introduction High-Performance Liquid Chromatography (HPLC: formerly referrd to ashigh-pressour liquid Chrometography ), is a techique in analytical chemistry used to separate, identify, and quantify each component in a mixture. The principle of chrometography, in chromatography a liquid is pumped through a bed of particles. The liquid is called the mobile phase and the particle the staionary phase . High performance liquid chrometography high performance liquid chrometography (HPLC) is basicallly a highy improved from liquid chrometography. Instead of solvent being chrometograhy allowed todrip though a column under gravity, it is forced through under high pressur of up to 400 atmospheres.That makes it much faster. All chrometograhy separation , includinHPLC operate under the sane basic principle; sepration of a samll into it’s  constituent parts because of the difference in the relative affinities of defferent molecules for the mobile phase an...