Stability Study & Analytical Science Services 2022-07-08T18:33:49+08:00

Stability Study & Analytical Science Services

◼︎ Stability Study Services

At Amaran Biotech, we support our clients with the stability storage and testing services to meet ICH requirements at every phase of the drug development program. Our plant is equipped with modern temperature and humidity-controlled chambers. The facility is fully validated and monitored 24/7 with alert monitoring & redundant power systems in place for accelerated and long-term stability testing. Our senior scientific staff can assess and support the development and validation of stability-indicating assays. The team can expertly execute force-degradation studies specialized for performance requirements, regions and study goals. We currently offer the following four storage conditions for stability samples:

  1. -20°C ± 5°C
  2. 5±3°C
  3. 25°C RH 60%
  4. 40°C RH 75%

◼︎ Analytical Science Services

Amaran Biotech’s scientific team provides the best-in-class services in method development, method validation, and sample testing to meet current USP/EP requirements. Our extensive experience and up-to-date regulatory knowledge allow us to always meet our clients’ needs.

1. Chemical Laboratory

Protein characterization:

  • RP-HPLC/size exclusion-HPLC
  • ELISA Reader
  • UVP BioSpectrum
  • UV Spectrophotometer
  • SDS-PAGE/Western Blot

Others:

  • DLS (Dynamic Light Scattering)
  • FTIR
  • Karl Fischer
  • HPAEC-PAD
  • GC/Head Space/FID/TCD
  • (Milliflex PLUS): Liquid sample microbiology test by Membrane Filtration
  • Analytical method development and validation

2. Microbiology Laboratory

  • Bioburden
  • ID for bacterial
  • Endotoxin
  • Sterility performed in SKAN isolator

3. Environment Monitoring Programs

  • Particle counter
  • Settle plate
  • Air Sampler
  • Water System