DANNALAB: CRO for Pharmaceutical XRPD & SAXS CMC Analysis

We specialize in X-ray characterization of pharmaceuticals and offer CMC analytical services in X-ray Powder Diffraction (XRPD - XRD) as well as Small Angle X-ray Scattering (SAXS). XRPD method most often used for characterization of small-molecule drugs while SAXS is an important tool to study biopolymers and drud delivery systems.

XRPD - X-Ray Powder Diffraction

• - cGMP XRPD characterization of API, formulations and finished dosage forms
• - Method development and validation, reporting, issuing CoA's
• - Identification and quantification with percents range LOD/LOQ's
• - Potent samples, samples in liquid matrix, samples in microquantities (0.002g)
• - Quality control during batch release with a turnaround time of up to 48h
• - Stability studies, testing of primary packaging
• - Analysis of pharmaceutical patents

SAXS - Small Angle X-Ray Scattering

• - cGMP SAXS characterization (rarely available)
• - Dedicated studies of drug delivery systems: liposomes, nanoemulsions, solid lipid nanoparticles
• - Reconstruction of nano-scale structure for biopolymers, peptides and virus structures

Compliance and Support

• - Compliance to USP<941>,Ph.Eur<2.9.33>, cGMP
• - NDA: as-is acceptance for efficient collaboration
• - Inspections: facility access is welcome
• - Support: same-day assistance, including regulatory inquiries
• - Expertise: in handling of cytotoxics, air-sensitive, microquantities, liquid dispersions etc.
• - Archiving: storage of prepared sealed samples for easy access


• - Track Record: during 23 year of operation all our reports have been accepted by regulatory authorities worldwide

Additional Services

• - On-demand synthesis of polymorpic forms
• - Complimentary synchrotron beamline studies
• - Complimentary free-electron laser studies
• - Complimentary Cryo-EM studies

Contact Us

Reach out to DANNALAB for assistance with:

• - Evaluating the quality of raw materials
• - Outsourcing quality control during batch release
• - X-Ray analytical support for your R&D project
• - In-depth physico-chemical characterization of drug substances or products
• - Expertise related to X-Ray specifications in pharmaceutical patents
• - Investigating deviations in your pharmaceutical production process
• - Non-trivial studies

We welcome all your inquiries and are here to support your pharmaceutical analysis needs.