Analytical chemistry services offered by deCODE chemistry provide access to a broad range of instrumentation and analytical techniques. Analytical chemistry is often one of the most time- and cost-sensitive activities in drug discovery and development. Our chemists understand the importance of deadlines, and the impact that accessibility to analytical data has on drug discovery and development initiatives.
Our analytical chemists serve a critical, central function by providing clients with the spectral and chromatographic data to facilitate key decision-making regarding the quality of candidate compounds during lead discovery and lead optimization. During the development phase of a program, our analytical chemistry team serves a vital role in successful product development. The optimization of rigorous analytical methods to measure the purity and integrity of an API are core strengths of our team. To support these operations, our Quality Assurance group has developed a comprehensive quality program along cGMP/ICH guidelines. Whether our clients require development of new analytical methods, or simply qualitative analysis using existing methods, our analytical chemistry team has the experience and resources to exceed expectations.
Analytical Method Development and Validation deCODE chemistry develops and validates analytical methods in support of chemical release of API or formulated drug products, impurity profiling, and stability studies. Methods can be developed using a wide range of analytical techniques including: HPLC, GC, GC/MS, LC/MS, and LC/MS/MS. All analytical method validation protocols are designed and performed according to USP or ICH guidelines. Comprehensive validation reports are provided upon the completion of each validation.
Reference Standard Certification Reference standards that are not available from an official source (i.e. USP/NF) must be evaluated to ensure that they are of the highest purity obtainable by reasonable efforts. Information regarding reference standards must include a thorough characterization to ensure correct information about the compound's identity, strength, quality, purity and potency.
Final purity potency of reference standards are assigned following collection and assessment of all analytical data by our analytical chemists. A comprehensive report and a Certificate of Analysis are issued to our clients upon completion of certification.
Stability Assessment deCODE chemistry offers a full range of stability testing services that includes various long term, accelerated, and stress stability assessments performed according to ICH guidelines. Stability studies are essential to our clients for systematic investigation of the conditions necessary to maintain a product's quality characteristics, and for establishment of the analytical methods necessary to identify and quantitate product degradants. Results from stability study projects are presented in a final stability data summary report. Interval reports can also be provided at various pull points upon a client's request. Stability study programs can provide valuable insight concerning stability issues that may impact product performance in the clinic.
Impurity Profiling and Identification Evaluation of impurities occurring in a lead compound can prove valuable when proceeding toward clinical studies with a promising drug candidate. deCODE chemistry can perform a feasibility study for impurity identification by LC/MS to determine the molecular ions of impurities. Online liquid chromatography/tandem mass spectrometry (MSn) studies are performed to isolate the molecular ions of interest in an ion trap mass spectrometer. This latter technique enables our scientists to construct fragmentation pathways of the impurities, which allow assignment of probable structures.
Preparative Separation deCODE chemistry is equipped with two preparative ProChrom LC 110 Dynamic Axial Compression (DAC) HPLC systems. These powerful tools enable purification of up to ten kilograms of crude material. The column design utilizes a piston to pack and unpack the chromatographic bed and maintain bed compression during use, which prevents the formation of voids in the bed. Any type of stationary phase can be used, including small particle-size (10 µm) media that generate high plate numbers. Our integrated chromatography infrastructure enables scale-up from analytical instruments to preparative separations as a straightforward operation. Our analytical chemists have successfully developed numerous separation methods and purified more than fifty kilograms of API, using both chiral and non-chiral stationary phases.
