Manufacturers must determine whether any impurities are present before bringing a new drug to market. If impurities are found, they must then assess their potential impact by analyzing their chemical composition. This process is known as structure elucidation.
Structure elucidation of unknown impurities is essential for ensuring the quality of active pharmaceutical ingredients and drug products. Impurities are classified as components of the active substance or the finished medicinal product that do not chemically correspond to the active substance, excipient or other additives. If an unknown impurity exceeds a specified limit, the structure of that impurity needs to be determined.
SGS has many years of experience when it comes to structure elucidation of unknown impurities.
This webinar will show how HPLC-MS techniques can be used for structure elucidation of unknown impurities. Special analysis techniques, e.g. (U)HPLC-QToF-MS(MS) or (2D)-(U)HPLC-QToF-MS(MS)) are necessary for structure elucidation given that impurities usually only occur in small quantities in active ingredients/drug products.
- The causes and types of impurities in drug substances and drug products
- Guidelines for impurities in drug substances and drug products
- Structure elucidation through the use of (U)HPLC-QToF-MS(MS) or (2D)-(U)HPLC-QToF-MS(MS)
Dr. Jochen Kirschbaum
Dr. Jochen Kirschbaum studied chemistry, received his doctoral thesis in the field of analytical chemistry in 1995 and has been working in Aachen since 2007, currently as Scientific Director at SGS Analytics Germany GmbH in Aachen.
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