Analytical Test Method Categories

Analytical Test Methods Categories


The categories of analytical test method categories for which validation data should be required are:

Category I: Analytical methods for quantitation of major components of bulk drug substances or active ingredients (including preservatives) in finished pharmaceutical products.

Category II: Analytical methods for the determination of impurities in bulk drug substances or degradation compounds in finished pharmaceutical products. These methods include quantitative assays and limit tests.

Category III: Analytical methods for determination of performance characteristics (e.g., dissolution, drug release).

Category IV: Identification tests.

Which Analytical Performance Characteristics are Required for each Analytical Test Method Category as per USP <1225>?

 For each analytical test method category, different analytical performance characteristic is needed.

 The following table describes which analytical performance characteristics is applicable to each analytical test method category:

USP 1225 table analytical test method validation


For more details on specific FDA expectations and how to perform an analytical test method validation, follow us.

validation templates online

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

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 Select the Analytical Test Method Categories.

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.


References: Analytical Test Method Categories


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!