XRD and SAXS Services for Characterisation of Pharmaceuticals

DANNALAB offers advanced microstructural characterisation based on X-Ray Powder Diffraction (XRD) and Small Angle X-Ray Scattering (SAXS).

We mostly focus on characterisation of pharmaceutical substances including finished drug products.

Different pharmaceutical substances – API’s, excipients, formulations, dosage forms and drug delivery systems - can be efficiently analysed by use of XRD and SAXS. XRD characterisation is often combined with the analysis of the available patents.

The information delivered by our services could be important for quality of your product.

Please download brochure with our pharma-related services here

Summary of XRD services

API and Formulations

Characterisation of API and excipients;
Characterisation of polymorphs;
Quantification of crystalline in amorphous substance, determination of particle size;
Compatibility studies

Drug Products and Finished Dosage Forms

Characterisation of API and excipients in finished tablets;
cGMP quantification of polymorphs, determination of LOD/LOQ;
Influence of processing;
Dosage form uniformity;
Production batch uniformity;
Stability studies;
In-line monitoring of structural changes at different Temp/RH;
Characterisation of drug product in packaging

Summary of SAXS services

Biopolymers in liquid

Particles size, shape, low-resolution structure, molecular weight, aggregation, second virial coefficient

Drug delivery systems: micelles and vesicles in dispersion

Fact of appearance, shape, size of the core and shell, details of electron density distribution
Particle interaction and aggregation (for high concentrations)

Drug delivery system + API in dispersion

Carrier binding with API, position of API in system, size and shape

Solids and Powders

Specific surface, particle size distribution, pore size distribution, properties of semi-crystalline polymers

Patent-related services

New patents:

Quality XRD and SAXS signatures measured in the lab or at the beam-line;
Drafting XRD claims for API, formulations and finished drug products

Granted patents:

Analysis of XRD claims, opinion on patent validity;
Testing of drug product for non-infringement

IP-related services

Anti-deformulation measures;
Counterfeit analysis

Read more about characterisation of pharmaceuticals or request our pharma-related case studies. Some general case studies are available here .

We offer confidentiality, free initial evaluation and up to 36h delivery time.
Read more...

Please contact us  for more information