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.
Peptide CMC
XRPD and SAXS for peptide therapeutics: aggregation, lipid carriers, solid-state, and CMC comparability.
Drug Delivery Systems
SAXS for liposomes, LNPs, nanoemulsions, and lipid-based carriers.
Nanoparticles
SAXS characterization of size distribution and inner structure.
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 in native solution
- Biosimilar comparability studies
- Aggregation and oligomerisation detection
- Stability and forced-degradation studies
Drug Delivery Systems
- LNP, liposome, and nanoemulsion structure
- mRNA-LNP assembly characterisation
- Lipid phase and polymorph analysis
- cGMP documentation available for selected methods
Peptide CMC
Solution-State Characterisation
- Aggregation and higher-order structure
- Oligomerisation and stability monitoring
- Lipid-carrier characterisation by combined SAXS and WAXS
Solid-State and CMC
- Peptide API solid-state: amorphicity, crystallinity
- Polymorph and salt-form characterisation
- CMC structural comparability
Medical Devices, Structures & Materials
Surfaces and Coatings
- XRR for thin films and multilayers
- GID for surface-near layers
- Coatings on implants and devices
Structures and Materials
- Transdermal patches
- Biocoatings (e.g., hydroxyapatite)
- Functional and porous materials
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