• Quality study on formulations and active pharmaceutical ingredients (API)
  • Pharmaceutical packaging compatibility study:
  • Protein characterization

Quality study on formulations and active pharmaceutical ingredients (API)

The platform is equipped with advanced instrumentation including HPLC (VWD/DAD/RID/ELSD)、UPLC (VWD/DAD) 、LC-MS/MS、GC-MS/MS、ICP-MS、ICP-OES、GC (FID/ECD) 、IC、UV、IR systems. In compliance with pharmacopoeia standards and regulatory guidelines, we conduct the following studies:

Chemical generic & Innovative API:

Structural elucidation of compounds, Quantitative analysis of related substances, Genotoxic impurity assessment, Elemental impurities profiling, Residual solvent evaluation, Particle size distribution analysis, Content determination and Stability study.

Excipient:

Quantitative analysis of related substances and Elemental impurity profiling.


Chemical generic & Innovative drug product:

Impurity structure identification, Related substance quantification, Genotoxic impurity assessment, Elemental impurities profiling, Residual solvent detection, Particle size distribution analysis, Dissolution and release profile studies, Content determination, Compatibility evaluation and Stability study.

Pharmaceutical packaging compatibility study:

The platform houses HPLC (VWD/DAD), UPLC (VWD/DAD), LC-MS/MS, LC-HRMS, GC-MS/MS, ICP-MS, ICP-OES, GC (FID/ECD), IC, SEM, and metallographic microscopy systems. We conduct comprehensive compatibility assessments between drug products and packaging materials, manufacturing components, and drug delivery devices per pharmacopoeia requirements.

Protein characterization

Leveraging state-of-the-art analytical platforms including LC-MS/MS, HPLC/UPLC-PDA, HPLC/UPLC-FLR, protein polypeptide sequencer, circular dichrometer (CD) spectrometer, dynamic light scattering (DLS) systems, microplate readers, differential scanning calorimetry (DSC) and other equipment, we deliver comprehensive characterization of protein-based therapeutics. Our capabilities span molecular weight determination, primary/secondary/higher-order structure elucidation, and post-translational modification (PTMs) analysis to ensure robust quality attributes assessment.