Analytical Chemistry

The analytical capabilities at HitGen are comprised of three parts, including the analytical chemistry for R&D, DMPK, 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.  

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

Characterization and purification of nucleotides, nucleosides and nucleic Acids

• Purity determination using HPLC, LC-MS and NMR

• MPLC and Prep-HPLC purification for mg to g samples

• siRNA characterization

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

Other analyses

• Native MS analysis

• Impurity isolation and analysis

• qNMR for absolute purity determination

• Water content determination

• Residual solvent determination 

DMPK analytical platform comes with two triple quadruple LC-MS/MS for High-throughput Quantitation Study and one LC-Q-TOF MS for Profiling / Screening Study, complete devices for bio-sample storage and processing, as well as automatic Informatics platform for pharmacokinetics, metabolite Identification and metabolomics Study.

In vivo DMPK capability

• SPF Animal Facility for Mouse and Rat

• General Pharmacokinetics 

• Cassette PK Screening for multiple compounds

• In vivo Metabolites Identification

• Safety Evaluation and Toxicokinetics

• Tissue Distribution

In vitro DMPK capability

• Microsomal Stability for Multiple Species

• Hepatocyte Stability for Multiple Species

• Microsome/Hepatocyte-based MetID, GSH adduction

• Plasma Protein Binding

• Cell Uptake and Efflux

• CYP450 inhibition Assay

• PAMPA-Based Permeability Assay

Quality control team is capable of the following tests and skillsets: 

Physicochemical characterization

• Lipophilicity (logP, logD)

• pKa

• Solubility (K.S, and T.S.)

• Stability (solid and in solution)

Analytical method development&validation

• Purity determination 

• Quantitative Method development 

• Method validation

Quality analysis and control

• Purity determination 

• Organic impurity and genotoxicity analysis 

• Elemental analysis

• Residual solvent analysis

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