cGMP-Compliant XRPD & SAXS Testing for Pharmaceutical CMC.

Specialized X‑ray characterization for pharma and biopharma.

If you need XRPD or SAXS data for development, batch release, stability, or patent analysis — with regulatory-ready documentation and fast turnaround — DANNALAB is your dedicated testing partner.

cGMP Accredited
Since 2014
USP <941>
Ph.Eur <2.9.33>
21 CFR Part 11
Traceable data
24–48 h
Turnaround available
QA-Approved CoA
Batch release ready

XRPD for Small‑Molecule Drugs

Batch Release & Quality Control

  • XRPD in release packages
  • QA‑approved CoA issued
  • 24-48 hour turnaround available

XRPD characterization →

Method Development & Validation

  • ICH-compliant validation
  • LOD/LOQ determination (0.17–0.5% wt)
  • Rapid feasibility assessment
  • Identification & Quantification

EU Import Testing: Pharmaceuticals imported into the EU require GMP testing in an EU laboratory (Directive 2001/83/EC). When & why? →

SAXS for Biopharmaceuticals & Drug Delivery

Biopharmaceuticals & Biosimilars

Higher-order structure of proteins, peptides, and antibodies in native solution. Biosimilar comparability studies, aggregation detection, and stability assessment.

SAXS characterization →

Drug Delivery Systems

Structural characterization of liposomes, LNPs, mRNA-LNP assemblies, nanoemulsions, and lipid-based carriers — analytical data to support your regulatory submissions.

SAXS characterization →

Medical Devices, Structures & Materials

Advanced characterization by XRR, GID, and specialized XRPD methods for coatings, implants, patches, and functional materials.

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Research & Innovation · Project Questionnaire · Test Cases & Application Notes