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
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)
Complementary Methodologies
When required, DANNALAB can access different complementary techniques including synchrotron beamlines (XRPD, SAXS, protein crystallography), Cryo-EM, AFM, and other specialized methods. Services provided through our partners, outside cGMP scope with full confidentiality preserved (anonymized samples, data erased after delivery). Available on project basis — complete the project questionnaire to inquire.