Analytical Services

The Analytical Technology Service (ATS) team at KriSan Biotech Co., Ltd. have extensive experiences in analytical research, in-process control, method development and product quality control. We provide a comprehensive and customized analytical services throughout all stages of drug development. This includes method development, qualification and validation; reference standard qualification and characterization and product quality. During the production, the team reviews, generates, and maintains analytical reports for raw materials and intermediates. Additionally, we issue Certificates of Analysis (COA) for final product releasing testing in compliance with current PIC/S GMP regulations. The stability programs are carried out to meet the requirements set forth by the ICH guidelines.

We provide the following services:

  • Analytical method development, method validation for raw materials, intermediates, and APIs
  • Compound identification and characterization including API, intermediate, impurities, degradation impurities and more.
  • Establishment of specifications for raw materials, intermediates, and APIs, along with release testing
  • Reference standard qualification and structure characterization
  • Conducting Stability studies
  • LIMS (Laboratory Information Management System, LabWare)
    • Managing GMP materials, in-process control, API and stability samples, which encompasses analytical results review and data integrity assurance.
    • Managing stability program and schedules
    • Managing and tracking the calibration schedules of instruments and equipment

Analytical Instrument at KriSan Biotech Co., Ltd.:

Chemical Property
  • HPLC
    • UV
    • PDA
    • RI
    • ELSD
  • UPLC
    • PDA
    • Fluorescence
  • GC / Headspace GC (FID)
  • Auto-titration
  • Total Organic Carbon
Physical Property
  • DSC
  • TGA
  • Polarimeter
  • Particle Size Analyzer
  • Karl Fischer
    • Volumetric
    • Coulometric
    • Thermoprep (oven)
  • Melting Point Apparatus
  • Vacuum Oven
  • Conductivity Meter
Spectroscopic Analysis
  • LC MS/MS (Q-Exactive plus)
  • ICP-MS / Microwave Digestion
  • FT-IR
  • UV-Vis
Stability Study
  • • ICH Storage Condition
    • -20±5°C
    • 5±3°C
    • 25±2°C / 60±5%RH
    • 30±2°C / 65±5%RH
    • 40±2°C / 75±5%RH
  • Photo Stability Testing
Strategic Partner
  • NMR
  • X-Ray Diffraction
  • Microbiological Testing