XRPD — X‑Ray Powder Diffraction
- Control of polymorphism and impurities
- Amorphous/crystalline ratio in actives and dosage forms
- Quantification of active in formulations (LOD/LOQ at the % level)
- Method development, validation, or transfer
cGMP-Compliant XRPD & SAXS Testing for Pharmaceutical CMC.
Specialized X‑ray characterization for pharma and biopharma.
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
Medical devices, coatings, implants, and functional materials.
Pharmaceutical Patents
Patent analysis and comparison of XRPD/SAXS data vs. patent claims and specifications.
Three Lines of Our Work
XRPD for small‑molecule drugs
Batch Release & Quality Control
- XRPD/SAXS in release packages
- QA‑approved CoA issued
- 24-48 hour turnaround available
- Identity, polymorphism, crystallinity
Method Development & Validation
- Acceptance criteria development
- ICH-compliant validation
- LOD/LOQ determination (0.17-0.5% wt)
- Rapid feasibility assessment
Process & Quality
Client NDAs accepted as‑is; USP<941>, Ph.Eur<2.9.33>, cGMP compliance; QA‑approved CoA; 21 CFR Part 11 traceable data; sealed samples archived; very fast turnaround feasible by request
🇪🇺 Import Testing: Pharmaceuticals imported into the EU require GMP testing in an EU laboratory (Directive 2001/83/EC). When & why? →
Research & Innovation
DANNALAB serves as an expertise center developing new methodologies through collaboration with industry and major research institutions. Dr. V.A. Kogan has authored multiple patents in methodology and instrumentation.
SAXS for biopolymers & vesicles
Small Angle X-Ray Scattering - SAXS is one of the main laboratory methods capable of probing structure of proteins, peptides and lipid assemblies in native (solution) environments.
SAXS for biopolymers & vesicles
Peptides/proteins, liposomes, LNP's; structure & stability
Patent analysis (SAXS)
Use SAXS descriptors (Rg, P(r), bilayer thickness, lamellarity) in claims/specs
Method Summary
- Rg, P(r) determination
- Oligomerization/aggregation
- Bilayer/assembly models
- Matrix compatibility
Deliverables
- Study protocol
- Model assumptions & fit
- Parameters with uncertainties
- Transfer package
Medical Devices, Structures & Materials
🔬 Advanced X-Ray Characterization for Medical Devices & Materials
Next to XRPD we offer specialized methodologies: X-Ray Reflectometry (XRR) for coating thickness analysis, Grazing Incidence Diffraction (GID) for surface-sensitive phase identification. Specialized XRD methods offered for curved surfaces (stents, implants), complex interfaces and in-situ studies of materials in contact with pharmaceutical formulation. This is critical for understanding coating-formulation interactions and material behavior in operational conditions.
Methods & what they answer
SAXS — Small‑Angle X‑Ray Scattering
- Studies of drug delivery systems: liposomes, lipids, nanoparticles
- Reconstruction of tertiary biopolymer structure
- Assessment of aggregation and particle size distributions
- Advanced modeling (e.g., lipid bilayers, mRNA assemblies)