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Physiochemical Characterization & Excipient Release

Using state-of-the-art analytical instruments, the Analytical Service Unit provides full compound characterization across full reference standards and structure characterizations to support global regulatory filings.

Full Structure Characterization for Regulatory Filings
+ 1D and 2D NMR with structure elucidation
+ Accurate mass spectrometry with mass accuracy within 3ppm
+ Infrared spectroscopy with absorbance band assignment
+ Ultraviolet spectroscopy with interpretation
+ Element analysis with interpretation
+ Optical rotation
+ Differential Scanning Calorimetry (DSC)
+ X-Ray Powder Diffractometry (XRPD)

Full Excipient Release per USP, ChP, EP and JP for Regulatory Filings
+ Melting point (MP) and solidifying point (SP)
+ Atomic absorption spectrometry (AAS)
+ Refractive index (RI) and conductivity
+ Nitrogen determination (Kjeldahl method)
+ Viscosity, turbidity (or clarity)
+ Specific gravity, bulk density
+ Heavy metals
+ As, Ba, Ca, Fe salt, sulfate, oxalate, chloride
+ Acid/iodine/saponification/peroxide value
+ Reducing sugar test
+ Particle size analysis for solid, liquid, injection
+ Micro limit and endotoxin tests