XRPD Method Development & Validation
Custom XRPD method development for polymorph quantification and pharmaceutical QC
Overview
At DANNALAB we can detect and quantify polymorphic impurities down to a limit of as low as parts of % wt. For finished dosage forms, in some cases, we are able to validate detection limit (LOD) down to 0.17% and quantification limit (LOQ) as low as 0.5% wt from total.
Why is this important? XRPD is a method specifically for the identification of polymorphs. The investigation of polymorphs (chemically identical substances in different crystallographic forms) is a key step in drug product development. Since polymorphic forms differ in their solid-state structure, they can have different aqueous solubilities and dissolution rates.
Presence of minor traces of patented polymorphic impurity may have significant legal implications as well.