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.
Browse by Application Area
Small Molecule Drugs
XRPD for polymorphism, crystallinity, and identity of APIs and formulations.
Biopharmaceuticals
SAXS for structure of proteins, peptides, and antibodies in native environments.
Drug Delivery Systems
SAXS for liposomes, LNPs, nanoemulsions, and lipid‑based carriers.
Nanoparticles
SAXS characterization of size distribution and inner structure.
Medical Devices & Materials
XRR, GID, and XRPD for coatings, implants, and functional materials.
Pharmaceutical Patents
Technical analysis of XRPD/SAXS data vs. patent claims and specifications.
Since 2014
Ph.Eur <2.9.33>
Traceable data
Turnaround available
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
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.
Drug Delivery Systems
Structural characterization of liposomes, LNPs, mRNA-LNP assemblies, nanoemulsions, and lipid-based carriers — analytical data to support your regulatory submissions.
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