GMP XRPD and SAXS Characterization of Pharmaceuticals

DANNALAB is an independent CRO 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).

X-Ray Powder Diffraction (XRPD or XRD) to Study Polymorphism and Crystallinity according to Ph.Eur. 2.9.33 and USP 941

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 including stability testing.

Express XRD Quality Control During the Batch Release

We offer affordable cGMP XRPD for quality control with a turnaround time of 3 to 6 days.

GMP Method Development and Validation for Identification and Quantitation

Among our services, we offer GMP method development and validation including nontrivial cases. The methods we offer are developed according to USP <941>, Ph.Eur. <2.9.33> and ICH guidelines. Our facility and procedures are compliant with the cGMP quality system.

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.

What We Can Do For You

Please contact DANNALAB if:

  • - You need an outsourcing partner for XRPD quality control during the batch release
  • - 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 independent study related to intellectual property (pharmaceutical patents)

All your inquiries are welcome.