Dannalab B.V. Information

GMP XRPD and SAXS Studies of Pharmaceuticals DANNALAB is an independent contract research company that specializes in physico-chemical studies of pharmaceuticals, biopharmaceuticals and drug delivery systems. To date we have successfully completed more than 450 projects, with 60+ active pharmaceutical substances. Our core expertise relates to X-Ray Powder Diffraction (XRPD or XRD) and Small Angle X-Ray Scattering (SAXS), combined with a range of complementary techniques. At DANNALAB we use XRPD (XRD) to identify the polymorphic type and crystallinity of an active pharmaceutical ingredient (API) in its pure form, as well as in formulation or dosage forms. We support our customers during research, pre-formulation and formulation stages. XRPD methods for API characterisation are also applied during stability studies and used for quality control during batch release. Small Angle X-Ray Scattering (SAXS) to Study Drug Delivery Vehicles and Biologics: We use SAXS to study the structure of drug delivery systems - micelles, liposomes and nanoparticulates. We also use SAXS to study the higher-order structure of biologics, their aggregation pathways and their stability patterns. You can find more information on our drug delivery and biopharmaceuticals pages. Pharmaceutical Patents To ensure effective and safe intellectual property management, we offer a range of services related to pharmaceutical patents. Good manufacturing Paractice (GMP) Quality System Among our services we offer method development and validation. Our facility and procedures are compliant with the cGMP quality system. The methods we offer are developed according to USP <941>, Ph.Eur. <2.9.33> and ICH guidelines.