Analytical Standards Guide

Here we'll go through the types of chromatography. But I think it's a good moment to discuss what the different analytical techniques are separated based on.  So, chromatography is a separation based on polarity differences but distillation is something where you separate based on boiling point differences, extraction involves separation based on acidity or basicity and spectroscopy is a way of identifying what kind of compound do you have by looking at what type of light rays it absorbs. If you are thinking about analytical techniques, it's good to know sort of how they work and their general operation but also understand what they separate based on because that can be a very commonly tested topic. Chromatography is all separated based on polarity differences. it separates based on a stationary phase that is rather polar and it has an adsorbent material which is something polar that other things bind with a mobile phase. Which is oftentimes a liquid sometimes a gas but

  This article teaches the basic definition and explanation of each performance characteristic. Typical analytical method parameters are specificity/ selectivity, the limit of the detection, limit of quantification, linearity & range, accuracy, precision, robustness/ ruggedness for analytical procedures. Specificity/ selectivity As per the ICH Q2 guideline, specificity is the ability to assist unequivocally the analyte in the presence of components that may be expected to be present. Typically, these might include impurities degradants matrix, etc.  As per the international union of pure and applied chemistry defined selectivity is the extent to which the method can be used to discover particular analytes in mixture or matrices without intervention from other components of similar behavior. Definition of the various document more or less agree with this interpretation. The international union of pure and applied chemistry recommended the term selectivity. While the pharmaceu

  In this article, we will learn method validation fitness for purpose of the analytical method What is analytical method validation? What is the difference between method validation and verification?  Why is the method validation necessary? When should methods be validated or verified?  How should the method be validated? What is analytical method validation? Different international documents have given the method validation definition like as per,  ICH Q2: the analytical procedure is to exhibit that it is suitable for its intended purpose.  United States of pharmacopeia USP: the process by which it's established by laboratory studies that the performance characteristics of the procedure meet the requirement for the intended analytical application  ISO 9000 : confirmation, through the stipulation of objective proof that the demand of specific intended use for application have been fulfilled  ISO/IEC 17025: confirmation, by examination and provision of object