GMP XRPD and SAXS Studies of Pharmaceuticals according to Ph.Eur. 2.9.33 and USP 941

DANNALAB is an independent contract research company that specializes in physico-chemical studies of pharmaceuticals, biopharmaceuticals, and drug delivery systems.

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.

X-Ray Powder Diffraction (XRPD or XRD) to Study Polymorphism and Crystallinity

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 characterization 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 Practice (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.

What We Can Do For You

Please contact DANNALAB if:

  • - Your R&D project requires X-Ray analytical support (we may be able to help in very non-trivial cases)
  • - You need an in-depth physico-chemical characterization of your drug substance or product
  • - You need an outsourcing partner for cGMP batch release of filing for marketing authorization
  • - You need a second opinion over an existing analytical result
  • - You need an independent opinion or study related to intellectual property

All your inquiries are welcome.