Analytical Chemistry and Quality Research

Capabilities:

The analytical capabilities at HitGen is comprised of two parts, including the analytical chemistry for R&D, and quality control. Each part is performed by an experienced and dedicated team.

Analytical chemistry for R&D: An experienced team with capabilities of characterization and purification of various analytes for DEL synthesis, oligonucleotides production, and chiral analysis for diverse analytical needs in the process of drug discovery. 

Ø  Platform for DEL Synthesis

•      UPLC-MS based high throughput analysis for DNA reactions

•      Prep-HPLC purification for DEL materials and products

•      Affinity Selection Mass Spectrometry (ASMS) for DEL on DNA Validation

Ø  Characterization and Purification of Nucleotides, Nucleosides Nucleic Acids

•      Purity determination using HPLC, LC-MS and NMR

•      Prep-HPLC purification for mg to g samples

•      siRNA characterization

Ø  Analysis and preparation of Chiral and Achiral Compounds

•      Chiral analysis and separation with SFC and prep-SFC

•      Achiral analysis and separation with HPLC and LC-MS

•      Structural elucidation using NMR, HR LC-MS, and GC-MS

Ø Other Analyses

•      Native MS analysis

•      Impurity isolation and analysis

•      qNMR for absolute purity determination

•      Water content determination

•      Residual solvent determination

Quality Research  ：An experienced team with capabilities of physicochemical analysis, method development and validation, quality control testing, and stability study systems.

 Ø  Physicochemical Characterization

•      Lipophilicity (logP, logD)

•      pKa

•      Solubility (K.S, and T.S.)

•      Stability (solid and in solution)

Ø  Analytical Method Development & Validation

•      Purity determination

•      Quantitative Method development

•      Method validation

Ø  Quality Analysis and Control

•      Purity determination

•      Organic impurity and genotoxicity analysis

•      Elemental analysis

•      Residual solvent analysis

Ø  Stability Study

•      In-house stability chambers for stress testing, accelerated studies, and real time studies for Packing material selection and container closure system

•      Degradation profile study

•      Designed stability protocols with proper intervals

Analytical Instruments: