Why are purity and contamination tests indispensable in drug analysis?
The manufacture of medicines has a direct impact on human health. Therefore, every medicine manufactured must be safe, effective and of high quality. Purity and contamination tests are an essential part of the quality control process to ensure the reliability of medicines. What do these tests mean and why are they indispensable? Let's examine this together.
What do purity and contamination tests mean?
Purity tests are methods for detecting undesirable substances that are not part of the expected active ingredient in a drug. These substances can come from the manufacturing process, the raw materials or from environmental factors.
In particular, contamination tests are carried out to check whether microbial contaminants, foreign particles or other harmful substances are present in the drug. These tests attempt to detect both chemically and biologically undesirable components in the drug.
Purity and Contamination Tests: Requirements and Legal Basics
Worldwide, the quality and safety of products in the pharmaceutical industry are subject to strict legal regulations. Purity and contamination tests form the basis of these regulations. Nanolab carries out numerous analyzes in this context.
The most important legal bases include:
I Q3A and Q3B Guidelines: Set chemical impurity limits and test requirements.
Medicine Books (USP, EP, JP): Standardize contaminant limits and test methods for drugs.
GMP (Good Manufacturing Practice) and GLP (Good Laboratory Practice) Standards: Ensure quality assurance of manufacturing and testing procedures.
National Drug Authorities Regulations: In Turkey, authorities such as the Turkish Drug and Medical Device Agency (TİTCK) are responsible for this area.
In addition to the legal requirements, we support the solution of problems that directly affect the health of the patients with these tests.
Modern Analysis Methods for Contamination and Contamination Tests
HeyUte, we prefer various modern methods for contamination and contamination tests that deliver high-precision, reliable and fast results. These include:
- Heavy Duty Liquid Chromatography (HPLC)
- Gas Chromatography (GC)
- Mass Spectrometry (MS)
- Inductively coupled plasma mass spectrometry (ICP-MS)
Microbiological Tests and Endotoxin Detection
These methods can be used to reliably detect even the slightest contamination and sources of contamination. This ensures the quality of the drugs and the safety of the patients at the highest level.