Analytical and Regulatory Services

Analytical and Regulatory Services

The R&D of analytical methods is a necessary key capability in developing API manufacturing processes. Our comprehensive analytical services include purity testing, characterization of polymorphs, analytical method development and validation, and stability testing. 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. 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 to the US FDA or other regulatory authorities.

ScinoPharm provides the below analytical services and technologies:

  • Development and validation of analytical methods as per ICH standards and the transfer of methods to the customer.
  • Quality control and release testing
  • Product purity and structure analysis and the identification of impurities using advanced technologies and the analysis of isomeric impurities. The analytical instruments include high-performance liquid and/or gas chromatography, mass spectroscopy, spectroscopy, and other advanced instruments.
  • Stress testing and packaging compatibility testing on products.
  • Setting up methods to analyze product impurities and establishing product specifications based on product properties.
  • Stability studies on APIs and formulations; 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), and DMF application are also included.

 

Analytical Instruments in SPT

 

Physical Property
Analysis

Chemical Property
Analysis

Spectroscopic
Analysis

  • VT-XRPD/VH-XRPD

  • DSC

  • TGA

  • Particle Size Analyzer

  • Dynamic Vapor Sorption

  • SEM

  • Melting Point Apparatus

  • Microbalance

  • Refractometer

  • Turbidimeter

  • Optical Microscope

  • Karl Fischer

  • Polarimeter

  • Dissolution Test

  • Conductivity Meter

  • HPLC(UV,PDA,Fluorescence,
    RI,Conductivity,ELSD,MALS)

  • UPLC(PDA,UV)

  • UCLC H-Class(PDA,CAD)        

  • GC/GC-Headspace
    (FID,ECD)

  • Capillary Electrophoresis

  • Ion Chromatography

  • Amino Acid Analyzer

  • Autotitrator

  • Stability Chamber

  • Photo Stability Chamber

  • Circular Dichroism

  • TOC

  • LC-MS(Single Quadrupole,
    TOF)

  • LC-MS/MS(Triple
    Quadrupole,Q-TOF)

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

  • MALDI-TOF MS

  • GC-MS(Single
    Quadrupole)

  • ICP-MS

  • NMR(400 MHz)

  • Fluorescence
    Spectrophotometer

  • FT-IR

  • UV-Vis