Pharmaceutical analysis plays an important role in both the development process and GMP manufacturing. Concerns about drug safety, costly development programs, complex manufacturing, market demands for evidence-based data and increased regulatory requirements are all issues that can be addressed through a better understanding of your drug substance, drug product or manufacturing process which, in turn, can only be achieved through experienced analytical studies and robust analytical data. Contract pharmaceutical analysis services are focused on supporting product development, GMP manufacturing and distribution, from an early phase of development through to manufacturing and post-marketing analytical support.
Nuclear Magnetic Resonance (NMR) analysis can provide detailed information about molecular structures and helps to confirm and establish the identity of pharmaceutical substances and impurities. Interpretation of NMR data can often be complex. Advanced NMR approaches may be required to obtain the most precise information in order for you to make decisions and progress development. Supporting critical stages of development, robust NMR data is necessary to support regulatory submissions or to ensure your product meets quality specifications.
Proton NMR is a method used for the structural characterization and identification of a sample. Only a few milligrams of sample is needed for analysis. Characterization is accomplished by identifying each hydrogen atom within a molecule based on its chemical shift in the 1H NMR spectrum relative to an internal standard (tetramethylsilane), peak splitting, and peak integration.