Our mission is to ensure the generation of accurate and precise findings.
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Reliable analytics are essential throughout cyclodextrin development, from raw material release and stability testing to characterization of novel derivatives and understanding the behavior of cyclodextrin–API complexes. CarboHyde provides specialized analytical support built around decades of practical experience with cyclodextrin chemistry, formulation and characterization.
For commonly used and commercially available cyclodextrins, we support release testing, identity testing, impurity profiling and stability testing using established pharmacopoeial and validated analytical approaches where applicable. This can support incoming raw material qualification, supplier comparison, batch release, formulation development and ongoing stability programs.Our analytical capabilities include HPLC, capillary electrophoresis (CE), UV spectroscopy, gas chromatography (GC), LC–MS and complementary physicochemical techniques. Methods can be adapted to the cyclodextrin grade, intended application and required specification.
Novel or highly substituted cyclodextrin derivatives often require dedicated analytical strategies because conventional methods may not adequately describe their substitution pattern, purity, impurities or structural characteristics.CarboHyde develops and validates analytical methods for new cyclodextrin derivatives, intermediates and related impurities, including methods for identity, purity, degree and distribution of substitution, residual starting materials, process-related impurities and degradation products. We combine chromatographic, electrophoretic, spectroscopic and mass-spectrometric techniques to build an analytical package appropriate for both development and future regulatory use.
Our analytical development is closely connected to process development, allowing analytical methods to evolve alongside route optimization, purification, scale-up, specification development and GMP implementation.
Understanding whether a cyclodextrin binds an active ingredient is only the beginning. Effective formulation development also requires understanding how strongly it binds, in what stoichiometry, how the complex is structured, how quickly it dissociates and how this interaction changes under relevant formulation conditions.
Our complex characterization studies can include:
Depending on the question, we apply techniques including isothermal titration calorimetry (ITC), NMR spectroscopy, HPLC, LC–MS and complementary analytical and computational methods. By combining experimental data with molecular-level understanding, we can support rational selection of the cyclodextrin and optimization of the final formulation.
Cyclodextrins can influence both the chemical and physical stability of an active ingredient, while the cyclodextrin or complex itself may also change during processing and storage. We therefore design stability programs that evaluate the complete system rather than looking at individual components in isolation.
Our services include forced-degradation studies, accelerated and long-term stability testing, formulation compatibility studies, monitoring of API degradation and impurities, cyclodextrin stability, complex integrity, API content, release behavior and other critical quality attributes.
Stability studies can be integrated directly into formulation, process-development and scale-up programs, providing the analytical evidence needed to select formulations, establish specifications and support subsequent CMC, regulatory and manufacturing activities.
