Analytical and Regulatory Services

Analytical Services

The R&D of test methods is an essential key capability in developing API manufacturing processes and drug product formulations. Our comprehensive analytical services include purity analysis, polymorphism characterization, test method development and validation, and stability study. All analytical instruments and data are managed through the Laboratory Information Management System (LIMS). The integrated data can be used to support the development of APIs and drug product. Moreover, it can be used as the basis for authoring drug master files (DMFs) by the legal department or supporting customers in preparing and submitting new drug applications or abbreviated new drug applications to U.S. FDA or other regulatory authorities.

ScinoPharm provides the below analytical services and technologies:

  • Development and validation of test methods as per ICH requirements and transfer of the test methods to customer.
  • Quality control and product release.
  • Using advanced technologies to determine the purity of product, chemical structure analysis and identification of impurities, analysis of isomeric impurities, polymorphism study, particle size distribution, and hygroscopicity study. The analytical instruments include high-performance liquid chromatography,  gas chromatography, mass spectroscopy, spectroscopy (NMR, IR, XRPD, etc.), and other advanced instruments.
  • Stress study and container closure system compatibility study on products.
  • Establish product specifications based on its characterizations and analyze the product following the established test methods.
  • Stability studies on APIs and drug products; assistance in preparing chemical manufacturing control (CMC) as material for submission to regulatory authorities at different stages of drug development. Moreover, the authoring of investigational new drug (IND) application, new drug application (NDA), abbreviated new drug applications (ANDA), and DMF application is also included.


Analytical Instruments in SPT


Physical Property

Chemical Property



  • DSC

  • TGA

  • Particle Size Analyzer

  • Dynamic Vapor Sorption

  • SEM

  • Melting Point Apparatus

  • Refractometer

  • Turbidimeter

  • Optical Microscope

  • Karl Fischer

  • Polarimeter

  • Dissolution Tester
    (Apparatus I, II, & IV)

  • Conductivity Meter



  • UPLC H-Class(PDA,CAD)


  • Capillary Electrophoresis

  • Ion Chromatography

  • Amino Acid Analyzer

  • Autotitrator

  • Stability Chamber

  • Photo Stability Chamber

  • TOC

  • LC-MS(Single

  • LC-MS/MS(Triple

  • LC–MSn(Ion Trap,
    Linear lon Trap/ETD)


  • GC-MS(Single Quadrupole)

  • ICP-MS

  • NMR(400 MHz)

  • Fluorescence

  • FT-IR

  • UV-Vis

  • Circular Dichroism