DANNALAB: CRO for Pharmaceutical XRPD & SAXS CMC Analysis
We specialize in X-ray characterization of pharmaceuticals and offer CMC analytical services in X-ray Powder Diffraction (XRPD - XRD) as well as Small Angle X-ray Scattering (SAXS). XRPD method most often used for characterization of small-molecule drugs while SAXS is an important tool to study biopolymers and drud delivery systems.
XRPD - X-Ray Powder Diffraction
- - cGMP XRPD characterization of API, formulations and finished dosage forms
- - Method development and validation, reporting, issuing CoA's
- - Identification and quantification with percents range LOD/LOQ's
- - Quality control during batch release with a turnaround time of up to 48h
- - Stability studies, testing of primary packaging
- - Analysis of pharmaceutical patents
SAXS - Small Angle X-Ray Scattering
- - cGMP SAXS characterization including method development and validation (rarely available)
- - Dedicated studies of drug delivery systems
- - Reconstruction of biopolymers, peptides and virus structures
Compliance and Support
- - Compliance to USP<941>,Ph.Eur<2.9.33>, cGMP
- - NDA: As-is acceptance for efficient collaboration
- - Inspections: Facility access is welcome
- - Support: Same-day assistance, including regulatory inquiries
- - Expertise: in handling of cytotoxics, air-sensitive, microquantities, liquid dispersions etc.
- - Archiving: Unique indefinite storage of prepared sealed samples for easy access
- - Track Record: Till now, all our reports have been accepted by regulatory authorities worldwide
Additional Services
- - On-demand synthesis of polymorpic forms
- - Complimentary SAXS/XRPD beamline studies
- - Complimentary Cryo-EM studies
Contact Us
Reach out to DANNALAB for assistance with:
- - Evaluating the quality of raw materials
- - Outsourcing quality control during batch release
- - X-Ray analytical support for your R&D project
- - In-depth physico-chemical characterization of drug substances or products
- - Expertise related to X-Ray specifications in pharmaceutical patents
- - Investigating deviations in your pharmaceutical production process
- - Non-trivial studies
We welcome all your inquiries and are here to support your pharmaceutical analysis needs.
