What is an Analytical Method?

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.



For more details on specific FDA expectations and how to perform an Analytical Method, follow us.

validation templates online

Three (3) Options to Create an Analytical Method Validation Protocol:

Option 1. You Can Create a Great Analytical Method Validation Protocol, Using a Template.

You can download a free sample of a validation template in .pdf format. 

To see the complete list of the most popular validation templates, click here.

In addition, you can request a quotation to buy online a full validation template document in MS Word format that is completely editable, ready to fill and adapt to your needs.

Option 2. We Can Bring You a Formal Training on How to Perform an Analytical Method Validation Protocols Using Our Template(s).

This option is recommended if you want to learn more about how to build a robust validation protocol. One of our expert(s) will provide online step-by-step training to your team (unlimited assistance) on how to build a reliable validation protocol using a template. You can improve your corporate validation procedures and policies incorporating our template sections.  It includes the template, an exam, and a training certificate for each assistant.  Request a quote now.

Option 3. We Can Create a Customized Analytical Method Validation Protocol.

One of our expert(s) will create and prepare for you a customized validation protocol with the inputs and specific information of your company. It may include, online support in document creation, execution, or final reporting, Request a quote online.




Analytical Procedures and Methods Validation for Drugs and Biologics Guidance for Industry


Validation of compendial methods


Picture of Ramon Cayuela, MS, BS, Chemical Engineering

Ramon Cayuela, MS, BS, Chemical Engineering

CIQA President and CEO.
I've been working in validation engineering since 1992 with many multinational pharmaceutical companies. I love sharing my passion and knowledge with others. If you have any questions about anything (or just have general questions). I will be more than happy to assist you. You can count on the BEST customer service on CIQA. I go to great lengths to make sure my clients are 100% satisfied with their purchases and check emails/messages consistently throughout the day. You can rest assured that everything being sold here is as-described or your money back. I look forward to working with you!