Analytical Standards Guide

  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 ...

  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 exami...

  Laboratory reagents have a multitude of functions when it comes to chemical reactions or processes. The purpose generally is to initiate a chemical reaction between the reactants while not being part of the formation of the product itself. Sometimes reagents are also used to determine if a certain product is produced, they can be of many forms and structures. Some types of reagents are pure substances and some are compounds or mixtures. They usually come in the form of inorganic chemicals and are sometimes made of organic molecular structures. Some reagents can be used for multiple kinds of reactions while others tend to be specific and serve their purpose for a certain reaction only. Following are types of lab reagents that are commonly used in laboratories. Hydrochloric Acid This acid is very corrosive and has many industrial purposes. It is commonly used to make PVC pipes and polyurethane . While in lower concentration this reagent is used in leather processing in hou...

In this blog, we are going to discuss what's actually going to do in the quality control lab and what kind of analysis is possible? And during analysis why standards are required? What kind of standards you can employ between the analysis? Before diving into deep discussion , the first thing you should know is the type of analysis commonly performed in the quality control laboratory. Type Of Analysis in The Quality Control Laboratory There are two kinds of analysis ·          Qualitative analysis ·          Quantitative analysis Qualitative Analysis Quality analysis when you are characterizing the physical properties of the material or substance. It means you are doing the description test. You are checking the solubility of the material substance. You are identifying the metals by spectroscopy or HPLC. Here you will not get any measurement values. Quantitative Analysis In a quantitative ana...