XRD(XRPD) and SAXS characterisation of pharmaceuticals and biopharmaceuticals
We offer: for small molecule drugs: XRD(XRPD) for - drug substance (API) and excipients: XRD (XRPD) quantification of polymorphs, XRD (XRPD) quantification of crystalline and amorphous content; compatibility studies;
XRD(XRPD)for intermediates and finished dosage forms: XRD(XRPD) charaterisation of effects of processing, quantification of polymorphism including FDF's; stability studies; QC testing of production batch (down to 24h turnaround)
SAXS for Biologics and biosimilars (in solution): SAXS investigation of properties of therapeutic proteins during development and manufacturing; studying particle size, shape and envelope structure; accessing conformation and aggregation pathways; SAXS investigation of drug delivery systems (monomers
SAXS investigation of solids and powders: probing specific surface (surface per unit volume) particle size and pore size distribution (nanoporosity) within the range of 1-60nm.
Patents (relevant to crystalline and amorphous forms): Assistance with drafting, XRD(XRPD),SAXS,WAXS properties for new patent; crystallographic and meso-scale properties for new patent; prior-art, clearance and invalidation research; crystallographic and image data analysis
Drug product identity: counterfeit product analysis, characterisation of drug product related to the suspected patent infringement
https://www.dannalab.com/