Physicochemical tests for pharmaceutical products within the framework of GLP
Given the impact of pharmaceutical products on human health, careful testing of these products is essential for their quality and safety. Physicochemical tests carried out as part of Good Laboratory Practice (GLP) use scientific data to confirm the compliance of pharmaceutical products with important criteria such as identity, purity, moisture content and microbiological purity. In our GLP-accredited laboratory, we offer our customers reliable analytical services with tests that are carried out in accordance with the monographs of the Ph. Eur. (European Pharmacopoeia) and USP (American Pharmacopoeia).
The role of physicochemical tests in GLP
GLP standards govern the planning, execution, traceability and reporting of tests, thus increasing the reliability of results. This allows manufacturers to carry out quality control of their pharmaceutical products according to international standards and ensure compliance.
The most important physicochemical tests we carry out as part of GLP
• Identification tests
Various physical and chemical methods are used to confirm that an active pharmaceutical ingredient or formulation is the right substance. These include:
- Spectroscopic methods (IR, UV, NMR)
- Chromatographic methods (HPLC, GC)
- Chemical reaction tests.
These tests ensure that the product has the identity indicated on the label. (Ph. Eur., USP)
• Purity tests
These tests are performed to detect potential contaminants of the active ingredient or formulation. These tests detect undesirable substances such as
- Solvent residues
- Reaction residues
- Decomposition products
They are carried out using limit value tests or quantitative analysis methods. (Ph. Eur., USP)
• Determination of water content
The moisture content has a direct impact on the shelf life and stability of many pharmaceutical products.
- The most common method, Karl Fischer titration, is used to accurately determine the water content in the product. (Ph. Eur., USP)
• Sterility test
In the case of pharmaceutical products that need to be sterile (solutions for injection, eye drops, etc.), it is determined whether live microorganisms are present.
- Sterility tests are performed under aseptic conditions.
- They are carried out in accordance with ISO 11737-2 and the pharmacopoeia references. (Ph. Eur., USP)
• Bacterial endotoxin test
This test is critical for parenteral products and certain medical devices:
- It detects pyrogenic bacterial endotoxins.
- It is performed using the Limulus-Amoebocyte-Lysate method. This test ensures that the products do not contain any substances that can cause fever after injection. (Ph. Eur., USP)