- Small Molecules
- Controlled substances
LC-MS is a valuable tool for the characterization of chemical degradants and impurities. By understanding the structures and sources of these related substances during early development, there is sufficient time to improve various processes, including API manufacturing, formulation and product process development. Depending upon the complexity of the molecule our partner HDH Pharma may perform additional analyses, either because the number of potential related substances exceeds the number of peaks (multiple co-eluting peaks) or because reasonable structures cannot be proposed based on the collected data.
- Method development — whether you just have powder or a basic method
- Non-GLP discovery analyses — getting good results fast, for internal use
- Method validation consistent with EMEA and FDA guidances
- Method transfer capabilities — cloning your method to our lab without change, regardless of LC-MS platform in your lab
- High throughput regulated sample analyses for preclinical and clinical studies