XRD for Characterisation of Pharmaceuticals

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

We 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 XRPD and SAXS. XRPD characterisation is often combined with the analysis of the available patents.

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

Please download brochure in pdf format here.

Summary of XRPD services

API and Formulations

Characterisation of API and excipients;
Polymorphs screening;
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 solution

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

Drug delivery systems: micelles and vesicles in solution

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 solution

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

Granted patents:

Analysis of XRPD 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 see our case studies for examples.
(For different from pharma XRPD applications, please download brochure here ).

We offer confidentiality, free initial evaluation and up to 36h delivery time.
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Please contact us  for more information