Characterization for Drug Substances and Drug Products
Characterization of drug substances and drug products plays an important role in the preformulation phase, which can provide crucial information that is useful for verifying raw material suppliers and understanding the product development process. The knowledge gained from drug substances and drug products characterization can also provide better specifications for material sourcing. BOC Sciences supports a variety of advanced techniques to analyze individual and overall properties of particles of drug substances and drug products.
Figure 1. Schematic representation of impurity-formation pathways for APIs and finished drug products. DMF is drug master file. (Wadekar, K. R.; Bhalme, M.; et al. 2012)
Our Services
To make it easier and better for researchers, BOC Sciences provides characterization for drug substances and drug products service in a competitive fashion. We have provided a more efficient way to increase the number of new drugs, greatly shorten the R&D cycle, and reduce the development costs. Our team leverages our expertise in preformulation development to provide you with the best chance of success for your molecule in the preclinical phase of development.
Molecular Structure Confirmation
- Structure elucidation studies include elemental analysis, mass spectrometry, liquid chromatography/mass spectrometry (LCIMS), Nuclear magnetic resonance (NMR) spectroscopy, UV-Vis spectroscopy, IR spectroscopy, FT-IR spectroscopy, stereochemical analysis, conformational/structural analysis, X-ray analysis, degradation analysis, and chromatographic analysis
- Our spectroscopy experts provide the spectral data to prove the structure of the drug substance and ensure the accuracy and adequacy of the study
- Elemental analysis and mass spectrometry studies are also applied to offer structural information on the various fragmentation patterns of molecules. While NMR studies are used to provide specific spatial information about the chemical structure
Physicochemical Characterization
Knowledge of the physical and chemical properties of the drug substance is essential for the development of an appropriate formulation. We carefully check the chemical and physical properties of the selected salt and provide documentation available regarding ease of processing as well as any potential impact on drug product processing equipment
- Many complementary assay techniques are used to verify the purity of Drug Substances and Drug Products including LC-MS, LC-NMR, refractive index and evaporative light scattering
- Examination of the solution stability of the drug in various solvents has been identified to understand the propensity for the drug substance to degrade in liquid formulations or wet processing steps
- Physical properties such as hygroscopicity, polycrystallinity, hydrate/solvent formation, solid-state stability and powder properties can be determined by X-ray powder diffraction, thermal analysis-differential scanning calorimetry (DSC) and thermal gravimetric analysis (TGA), and hot-stage microscopy
- Particle size distribution of multiple batches are measured as an indicator of process stability
- Support various particle size techniques including laser light scattering, sieve analysis, and optical microscopy
- The organic impurity profile of the drug substance includes the actual and potential impurities that are most likely to arise during the synthesis, purification and storage of the drug substance
- We provide the results of all relevant batches and investigate the structure and source of the impurity
- An impurity profile is available regarding the inorganic impurities for each drug substance lot used in toxicological evaluation, primary clinical studies, stability evaluations of both drug substance and drug product, validation of the manufacturing process, and the development of the drug product
Why choose BOC Sciences?
Our dedicated CMC team has provided tailored solutions to our clients from engagement to launch. With many years of industry experience, we provide clients with the following:
- Comprehensive, integrated CMC services with a flexible service model that grows with your programs
- Knowledgeable industry experts who deliver scalable, actionable insights
- World-class facilities and equipment that remain at the forefront of the global pharmaceutical research, analytical and development standards
- Our comprehensive services support products at every stage of the product lifecycle, from early-stage discovery to full commercial cGMP manufacture
- A focus on risk management that is designed to ensure completion of your technical goals
BOC Sciences provides professional, rapid and high-quality services of characterization for drug substances and drug products at competitive prices for global customers. Personalized and customized services of characterization for drug substances and drug products can satisfy any innovative scientific study demands. Our clients have direct access to our staff and prompt feedback to their inquiries. If you are interested in our services, please contact us immediately!
Reference
- Wadekar, K. R.; Bhalme, M.; et al. Evaluating Impurities in Drugs (Part I of III). Pharmaceutical Technology. 2012. 36(2): 46-51.
