GMP XRPD and SAXS Characterization of Pharmaceuticals.
DANNALAB is an independent CRO that specializes in physico-chemical studies of pharmaceuticals. Our core expertise relates to X-Ray Powder Diffraction (XRPD) and Small Angle X-Ray Scattering (SAXS).
At DANNALAB we use XRPD 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. Among our services, we offer GMP method development and validation for identification and quantification. The methods we offer are developed according to USP <941>, Ph.Eur. <2.9.33> and ICH guidelines. For quality control during the batch release we offer affordable cGMP XRPD with a turnaround time of 3 to 6 days. Our facility and procedures are compliant with the cGMP quality system. We use SAXS to study internal structure of drug delivery systems – such as lyposomes and nanoparticulates. We also use SAXS to study the higher-order structure of biologics, their aggregation pathways, and their stability patterns. To ensure effective and safe intellectual property management, we offer a range of services related to pharmaceutical patents.