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
  • - 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 including method development and validation (rarely available)
  • - Dedicated studies of drug delivery systems
  • - Reconstruction of 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: Unique indefinite storage of prepared sealed samples for easy access

  • - Track Record: Till now, all our reports have been accepted by regulatory authorities worldwide

Additional Services

  • - On-demand synthesis of polymorpic forms
  • - Complimentary SAXS/XRPD beamline 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.