Polymorph identification in pharmaceuticals ensures the API within your drug product exhibits the intended behavior.
The FDA often requires polymorph data when evaluating a New Drug Application or Abbreviated New Drug Application. Why? A single active pharmaceutical ingredient (API) can exist in different crystalline and structural forms that, although chemically identical, demonstrate varying levels of efficacy, safety, stability, and bioavailability. Making matters more complex, polymorphism can result at any time during a drug product’s market journey, from formulation preparation to final product transportation and storage.
Gateway Analytical offers polymorph identification for any stage of drug development or the post-market life for product formulations of nasal sprays, inhalable drugs administered through metered dose inhalers (MDI) and dry powder inhalers (DPI), creams, gels, ointments, and more. Our experts perform this service in two phases: Feasibility and Full Testing.
During Feasibility, we determine which Raman technique (RCI, SPE-Raman, or manual confocal Raman spectroscopy) can best differentiate between various polymorphic forms of interest for our specific customer’s formulation. Once the testing technology is optimized, we provide spectral overlays exhibiting the technology’s capability to distinguish polymorphic forms, an assessment of the polymorphic form of the crystals analyzed, and a statement of conclusion from polymorph identification testing.
Contact our experts today to see how Gateway Analytical can help you to cover this unique regulatory requirement.