What is an Analytical Method?

What is an Analytical Method?

A technique that allows us to measure and determine the concentration qualitatively or quantitatively the composition of a chemical compound or materials using an Analytical Method.

Exist a wide range of techniques used for analysis, from simple weighing to very advanced techniques using highly specialized instrumentation.

The most common analytical method techniques used in analytical chemistry are the following:

Titration, (Titrimetry), based on the quantity of reagent needed to react with the analyte;

Electroanalytical methods, including potentiometry and voltammetry;

Spectroscopy, based on the differential interaction of the analyte along with electromagnetic radiation;

Chromatography, in which the analyte is separated from the rest of the sample so that it may be measured without interference from other compounds;

Gravimetric analysis; weighting

Radioanalytical chemistry;

Surface analysis

There are many more analytical method techniques that have specialized applications, and within each major analytical technique, there are many applications and variations of the general techniques.

Statutory and Regulatory Requirements – Analytical Method

Test procedures for assessment of the quality levels of pharmaceutical products are subject to various requirements. According to Section 501 of the Federal Food, Drug, and Cosmetic Act, assays and specifications in monographs of the United States Pharmacopeia and the National Formulary constitute legal standards.

The Current Good Manufacturing Practice regulations [21 CFR 211.194(a)] require that test methods, which are used for assessing compliance of pharmaceutical products with established specifications, must meet proper standards of accuracy and reliability. Also, according to these regulations [21 CFR 211.194(a)(2)], users of analytical methods described in the USP and the NF are not required to validate the accuracy and reliability of these methods, but merely verify their suitability under actual conditions of use.

Recognizing the legal status of USP and NF standards, it is essential, therefore, that proposals for the adoption of new or revised compendial analytical methods be supported by sufficient laboratory data to document their validity.