Identification Testing in Pharmaceutical Products | OECD GLP Compliance

Pharmaceutical Product Studies under GLP

What are Pharmaceutical Products?

Pharmaceutical products are medicines and similar medical substances used to prevent, treat or alleviate the symptoms of diseases. They are available in different forms such as tablets, capsules, injections and creams. The efficacy and safety of these products depends on the analysis and testing processes as well as the production process.

Why are Pharmaceutical Products Tested?

Pharmaceutical products that directly affect human health must undergo serious control processes in terms of both content and production conditions. The main purpose of the tests:

Ensuring the accuracy of active substances and excipients
Detecting harmful impurities - Providing scientific data to regulatory processes
Meeting GMP (Good Manufacturing Practices) and GLP (Good Laboratory Practices) requirements
Providing safe and effective products to the end user

What are Identification Tests in Pharmaceuticals?

Pharmaceutical Identification Tests are analyses performed to confirm the identity of the active substance or substances that must be present in a drug or pharmaceutical product. These tests are carried out to prove that the product contains the correct ingredients, is not counterfeit or falsely formulated and complies with the labeling.

Purpose of Identification Tests:

Precisely determine the presence of the active substance of the product
Detecting false or counterfeit products
To reveal formulation errors that can be made during production
Ensuring reliability in regulatory and quality control processes

Commonly Used Identification Test Methods:

Method	Description
IR Spectroscopy (Infrared)	It is used to confirm the chemical structure of the molecule. Each compound has a unique IR spectrum.
UV-Vis Spectroscopisi	It is especially used for the identification of colored compounds. Analyzes the light absorption properties of the molecule.
HPLC (High Performance Liquid Chromatography)	It provides high accuracy for the separation and identification of complex mixtures.
TLC (Thin Layer Chromatography)	It is a convenient and economical pre-test method, comparison with reference standards.
NMR (Nuclear Magnetic Resonance)	It is an advanced method for detailed analysis of molecular structure. It is often used in R&D studies.

What Do We Offer as Nanolab?

Nanolab is an expert laboratory providing GLP-compliant analysis services specific to the pharmaceutical industry. The main services we offer to pharmaceutical manufacturers and R&D companies:

Active substance identification tests
Purity and impurity analysis
Stability tests
Microbiological analysis
Packaging compatibility tests

With our state-of-the-art equipment and team of experts, we analyze your pharmaceutical products for compliance with national and international standards.

Nanolab Laboratories Group continues to provide services within the scope of Pharmaceutical Analysis. You can also consult us on Plant Protection Products (PPP) as a laboratory with GLP Certificate of Conformity.

For more information, please contact us.
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