Scintel Pharma excels in meeting diverse custom synthesis requirements, whether you need milligram quantities of a metabolite or several kilograms of a complex molecule. Our rapid response capability ensures swift fulfillment of any custom synthesis request, encompassing the synthesis of reference standards, impurity markers, and New Chemical Entities (NCEs). Depending on the molecule’s complexity, we adapt our approach, utilizing chemical or bio-catalytic methods, tailored to your specifications.
For clients prioritizing speed, our rapid scale-up facility expedites the process. Leveraging our R&D facility, we offer cost-competitive solutions for projects where efficiency is paramount. Equipped with cutting-edge instrumentation and a vast array of scale-up equipment, Scintel ensures that your custom synthesis projects benefit from both precision and efficiency. Our experienced scientists are dedicated to delivering quality results, no matter the size or complexity of your synthesis needs. Trust Scintel for quick, efficient, and tailored custom synthesis solutions.
Process Safety Assessment
Scintel’s labs feature cutting-edge process safety tools, such as RC-1 reaction calorimeters, HEL Thermal Screening units, and differential scanning calorimeters. These resources empower our scientists to proactively assess and address potential hazards, with Hazop studies integral to our process safety analysis (PSA). Leveraging our extensive experience, we specialize in developing secure, efficient, and robust processes to meet your API, intermediates, and specialty chemical supply requirements. Trust Scintel for advanced safety and reliable solutions.
Chiral Separation Technologies
We specialize in chiral separation technologies, offering comprehensive separation services throughout the drug development process. Our expertise includes isolating materials of interest, including controlled and potent compounds, using both classic and chromatographic techniques. Purification of APIs, intermediates, impurities, or degradants is routinely carried out via HPLC or flash chromatography on gram to kilogram scales. Chiral resolutions of racemates are performed using Preparative HPLC or Flash Chromatography on a multigram scale. We characterize the isolated active substances using various analytical methods such as NMR, HPLC, specific optical rotation, LC-MS, IR, etc. Our services can be utilized independently or seamlessly integrated with development and manufacturing efforts, either within Scintel or at a customer-preferred site.
Impurity Isolation & Characterization & Supply
At Scintel, we prioritize controlling process-related impurities and degradants in the development of robust manufacturing processes. We systematically monitor these through LC-MS profiling, identifying low-level impurities in drug substances, products, or metabolites. Our approach includes small-scale isolation, forced degradation studies, and chemical derivatization. We develop chromatographic methods for impurity enhancement and isolation, utilizing advanced spectroscopic techniques such as NMR, MS, FTIR, and UV. For target impurities, we offer scale-up processes, isolating gram quantities for use as reference material, with rigorous analytical testing for relative response factors.
