Analytical Capabilities

Purisys offers complete in-house analytical testing capabilities, including ICH compliant stability studies. We are fully licensed for handling Class I to Class V controlled substances as a part of this capability.

Services include:

Analytical method development, validation, and transfer using regulatory framework (USP, ICH, etc.)
Impurity identification and forensic investigative testing
Preformulation (e.g., excipient compatibility, solubility, etc.)
Product release and stability testing

Analytical Equipment

Liquid Chromatography

6 Different makes/models
HPLC and uHPLC
Detectors: VWD/TUV/DAD/PDA, Single quad MS, Triple quad MS, ELSD, CAD

Gas Chromatography

Agilent 6890 with FID
Shimadzu GC with MS and FID
Headspace and Direct Inject Systems

Physical Properties

Laser Diffraction (wet and dry dispersion)
High Powered Optical Microscopes
XRPD
DSC/Melting Point
Specific Surface Area
True Density
Bulk/Tapped Density
Powder Rheometry

Wet Chemistry tests (KF, Titration, etc.)

Polarimetry

Stability

2x ICH compliant cGMP stability chambers Photostability Chamber

NMR

Various Other Common Techniques