The Characterization of Polymer, to be used in complex drug formulation, is a key requirement. To fulfill this requirement considering the regulatory aspects, at Nomisma Healthcare, detailed study & analysis are done which covers the following tests.
Identification by 1H-NMR.
Identification by FT-IR.
Inherent viscosity (IV).
Monomer ratio by NMR study.
End group identification by 13C NMR
Block length identification by 13C NMR
Water content by Karl Fischer.
Glass transition temperature (Tg) by DSC.
Free acid content by a titrimetric analysis.
Residual monomer content by 1H-NMR
Bioburden test (total aerobes, spores, and anaerobes)