Analytical Development and Quality Control

At Hitgen we understand the importance of analytical support from laboratory process development to production through to regulatory data submission. Our dedicated analytical science and quality control teams provide our clients with a full spectrum of analytical method development, validation and testing services to support your needs in drug discovery.  We extend our services throughout the product life cycle with stability management teams.

Analytical science and quality control services

• Physical and chemical testing of compounds, such as LogP\LogD\pKa\BCS\XRD\TGA\DSC\IR\UV\NMR\ee.

• The kinetic Solubility and stability analysis of compound solution in different pH solution, and the stability of the solution

• Structure elucidation of compound

• Analytical method development and validation 

• API and drug product release testing 

• Reference standard characterization and qualification 

• Genotoxic/elemental impurities method development, validation and testing

• Impurity/degradant isolation and structure elucidation

  
  

Stability testing services

• API and clinical trial material(CTM)stability study for IND/NDA/ANDA

• Primary/registration stability/formal stability study (FSS)/long term stability study (LTSS)

• Photo-stability

• Stress testing

Analytical technologies

• Chromatography: UPLC, HPLC, LC-MS, LC-MSMS, GC, GC-MS

• Detection: UV, DAD,PDA,ELSD,FLRD,RID

• Identify: NMR, FT-IR ,Q-TOF,UV,XRD,TGA\DSC,ee

• General testing: KF, automatic potentiometric titrator, Polarimeter

• Elemental analyzer: ICP-MS

• Solid state characterization: Melting Point Apparatus

• Stability & photo-stability chambers

MS instrumentation at Hitgen includes

• Waters Xevo TQ-S UPLC MS/MS

• Waters Xevo G2-XS UPLC QTof MS

• Agilent 7890B/ Agilent 5977 GCMS

• Agilent 7800 ICP-MS