Chemical impurity analysis is a scientific process applied to identify and isolate unknown materials in chemicals, polymers, packaging, pharmaceuticals, finished products.
Various impurity analysis methods performed in advanced laboratories include high performance liquid chromatography (HPLC) combined with UV detection (HPLC/UV methods). UV detection helps identify impurities or decomposes in drug substances based on maximum absorption. This technique is one of the most important and versatile analytical methods available in terms of contamination profile, especially for routine analysis, with its selectivity, i.e. the ability to quantitatively identify many individual components present in a sample using a single analytical procedure.
In the chemical field, the term impurity refers to a chemical substance that is in a limited chemical phase and differs from the chemical composition of that phase. Impurities usually occur in small amounts and are of little concern in the chemistry itself. In pharmacy, by contrast, impurities increase the potential for toxicity, side effects, and serious consequences for human health and the environment. Pharmaceutical regulatory agencies have therefore developed regulatory and strategic systems to minimize the chemical presence or biological effect of such substances.
Modern analytical methods show the presence of impurities, while interpretations of the corresponding results are supervised by risk management and accepted thresholds.
The United States Pharmacopeia (USP) defines an impurity as: any component of a drug substance that is not a chemical entity defined as a drug substance, as well as any component that is not a formulation component for a drug product. Impurities in the drug active pharmaceutical ingredient or drug product may arise due to synthetic/manufacturing processes, degradation, storage conditions, container, excipients, or contamination. They may be of the identified or unspecified, volatile or non-volatile, organic or inorganic type.
Pollution sources must be carefully classified as different legal requirements and management strategies need to be established and adhered to. However, despite the increase in the search for impurities, there are still some problems in the development of identification technologies for degradation products and pathways.
Our organization also provides impurity testing services with its trained and expert staff and advanced technological equipment, among the numerous test, measurement, analysis and evaluation studies it provides for businesses in various sectors.
To get an appointment, to get more detailed information or to request an evaluation, you can ask us to fill in our form and reach you.
