cGMP XRPD and SAXS Services for Characterisation of Pharmaceuticals

DANNALAB is a contract research company specializing in X-Ray studies of pharmaceuticals and biopharmaceuticals. We support our customers during research, pre- formulation, formulation and batch manufacturing stages.

You can download brochure listing our services here.

XRPD to Access Polymorphism and Crystallinity in Small Molecule Drugs

At DANNALAB we use XRPD to identify the polymorphic type, quantity and crystalline state of API in pure form as well as within formulations or dosage forms. At different stages of drug product development, XRPD (X-Ray Powder Diffraction) is used for the characterisation of active pharmaceutical ingredients (API), excipients, intermediates and mixtures in solid forms. These methods of characterisation are also applied during stability studies and for quality control during the batch release.

We following USP <941>, Ph.Eur. <2.9.33> and ICH for identification and physicochemical characterisation against available standards. Read more...

SAXS to Access Structure of Biopharmaceuticals

With SAXS (Small Angle X-Ray Scattering), we are targeting the characterisation of structure-related factors that are correlated with biological activity of biopharmaceuticals.

We use SAXS to identify:

  • -higher-order structure in solution, molecular mass, conformational space and oligomeric state
  • -aggregation pathways and their physico-chemical mechanisms
  • -stability

We also use SAXS to determine the properties of drug delivery vehicles and nanoparticulates.

Pharmaceutical Patents

To ensure effective and safe IP management, we offer a range of services related to pharmaceutical patents.

cGMP quality system

Our facility and procedures are compliant with cGMP quality systems. The methods are developed and validated according to ICH guidelines.