Understanding API Impurities and their Importance in the Pharmaceutical Industry

16 May 2024

Impurities in pharmaceuticals are unwanted chemical substances that remain in active pharmaceutical ingredients (API) or develop during manufacturing or appear due to the degradation of the molecule itself. The presence of these unwanted chemicals, even in small amounts, can influence the efficacy and safety of the pharmaceutical product. Control of impurities is currently a critical issue for the pharmaceutical industry.

Impurities in pharmaceuticals are usually classified according to their origin and nature. They can arise from various sources such as starting materials, reagents, intermediates, or by-products of the synthetic process. Analysing impurities in APIs is crucial to ensure the quality, safety, and efficacy of pharmaceutical products. Techniques such as chromatography, spectroscopy, and mass spectrometry are commonly used for profiling and quantifying impurities.

Impurities in the active pharmaceutical ingredient are essential to detect and characterise unwanted substances in medicines. TLC, one of our brands specialising in the custom synthesis of complex organic compounds used as reference standards in the biomedical and pharmaceutical industries, includes an extensive catalogue with a wide variety of API Impurities, including deuterated APIs, among others.

Through rigorous chemical analysis, isolation, and characterisation processes, TLC ensures the quality and reliability of its products, providing valuable tools for pharmaceutical research and development. Discover TLC's API Impurities and other high-quality product references at CymitQuimica. Here are some of the TLC API Impurities available for purchase on the website:

For any queries or assistance, our dedicated support team is available to offer you assistance whenever you need it. We are constantly dedicated to supporting your research needs and committed to ensuring the success of your pharmaceutical processes.