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 ...

  What are Reference Standards? Solutions of exactly known strength are called standard solutions. A standard solution contains a known weight of chemicals in a definite volume of solution. A standard solution is prepared by dissolving an accurately weighed quantity of highly pure substance in a definite volume of solvent. Types of Standard Solutions There are two types of standard solutions first is primary standard and secondary standard. Primary standard Any reagent or chemical which has all these properties is suitable for use as a primary standard: It is extremely pure.  It is highly stable.  It is anhydrous.  It is less hygroscopic.  It has a very high molecular weight.  It can be weighed easily.  It should be ready to use and available .  It should be preferably nontoxic Following is the detail of a few properties Purity: To qualify as being the primary reference standard, a chemical needs to be extremely pure. Preferably...

  The drug reference standard is a standardized substance that's utilized in the pharmaceutical industry as a base of measurement for similar substances where the precise active substances of a new drug are unknown. A reference standard provides a calibrated level of biological effects to compare new preparations of the drug. Analytical drug reference solutions and patient education materials put the best available information into the hands of clinicians and patients. They simply analyze the information regarding dosage, efficacy, interactivity , and allergies, even suggesting alternate therapies as appropriate. Drug reference standards are highly characterized physical specimens used in analytical testing by pharmaceutical and related industries to help ensure the identity strength, quality, potency , and purity of medicines, drugs, biologics, and excipients dietary supplements and food ingredients. All chromatographic reference standards are supplied with a certificate of an...