Home > Analytical Lab Service

  • Process Validation for Accuracy, Precision, and creditability of product with USP and ICH Guideline

  • Test for deciding to release API and final product

  • Establish the term of validity and condition of preservation for Drug substance and Drug product

  • HVAC(Air) Monitoring
  • Water(PW, WFI) Monitoring
  • Gases(Compressed Air, N2, CO2, O2) Monitoring

Eligibility test of materials

Biochemical Test IEA, SDS Page/Westen Blot, EIA, HCP, etc
Chemical Test HPLC(Including SEC, RP, IE)
Peptide mapping, GC, Amino Acid Content,
N-tetminal sequencing, C-terminal sequencing,
Scanning Densitometey, pH, Particulate Matter
Reconstitution/Appearance, conductivity, TOC, etc
Microbial Test Sterility, Endotoxin, Bioburden Mycoplasma
Total Microbial Count, Microbial Identification, etc
Bioassay Cell-based bioassay/Mycoplasma, Potency, etc