Impurity Isolation and Identification

Analytical testing is a critical part in every step of drug development and manufacturing. The qualitative and quantitative results generated from validated analytical testing provide first-hand information to control and ensure the quality and safety of raw materials, intermediates, and finished products. Like many other CMC (chemical, manufacturing and control) activities, analytical testing is also frequently outsourced. Many factors are attributed to this rapid market growth, including continuous outsourcing from pharmaceutical companies, growing pipelines for biological candidates, and increasing demand for more analytical details on drugs and process development by regulatory agencies. In response to the changing market dynamics, service providers are striving to provide analytical testing with quality, accuracy, and robustness all within tight timelines. As the contract research organizations (CROs) have become more integrated, small analytical labs need to establish their niche to succeed. Global contract anlytical Laboratories provide QC laboratory analysis, method development, validation and expert advice for both finished products and raw materials for pharmaceutical and biopharmaceutical companies. Impurity isolation and identification offers you critical information on the structure of your impurity, triggering synthesis efforts that contribute directly to CMC filings and better define conditions for the GMP synthesis process. PREPARATIVE SCALE IMPURITY ISOLATION APPLICATIONS include Structure Elucidation, Reference Standards and Toxicology Studies. Instrument & Detection Systems is done via SFC – Preparative & Analytical, HPLC – Preparative & Analytical, RPLC – Preparative & Analytical, UPC2, UPLC, GC/MS, ELSD, MS, CAD Detection, PDA/UV, NMR, Accurate Mass MS etc. Impurity synthesis and analysis is a very important step during the development of new drugs and pesticide. Pharmaceutical and pesticide impurities are chemicals, other than the main active ingredients, generated during the production, storage and other processes. The presence of the impurities affects the pharmaceutical, pesticide safety and the stability. So the drug production, storage and other processes must be strictly controlled to avoid the formation of impurities. The impurity is an important indicator of the quality control of drugs. Qualitative and quantitative analysis of impurities are always required in medicine, pesticide reporting, new product developments and quality control. CRO’s develop chromatographic and classic methods for the enhancement and isolation of critical impurities. Upon isolation of milligram quantities from the original source via HPLC or SFC, they use advanced spectroscopic techniques such as nuclear magnetic resonance (NMR), mass spectrometry (MS), Raman, infrared and ultraviolet. They apply these techniques directly or in conjunction with capillary NMR and hyphenated techniques such as LC/MS/MS, accurate mass and LC-NMR for fast, accurate identification of materials of interest. Upon identification of the target impurity, CRO’s offer scale-up processes for the isolation of gram quantities of impurities or degradants for use as reference materials. Relative response factors are also determined based on rigorous analytical testing. Extensive structural chemistry services for small and large molecules that include: Impurity and degradation product identification and structural elucidation, Characterization of API, product, reference standard and other pharmaceutical ingredients, Molecular weight determination for large biomolecules, Support for regulatory documentation for IND, MAA, DMF, Analytical reference standards qualification etc.