GMP Testing Services

In the complex drug development pipeline, there are several key areas where a need for product or materials testing becomes necessary. Singota has a unique niche for delivering these testing capabilities to those in need, with a specialty in parenteral product testing. GMP testing services include:

  ICH Thermal Stability Test Programs

  Compound Testing

  Raw material testing for manufacturing use

  Release and CoA generation

  Trials for Solubility, pH, Degradation, Potency, Purity, Reconstruction

  Testing of cytotoxic compounds

  Thermal Cycling and Excursion Testing

  Materials Compatibility Testing (e.g.: infusion sets, IV bags, stoppers, etc.)

  Post-Packaging Identity Testing (Blinded and Unblinded)

Singota Solutions - Testing
Singota Solutions - Testing

ICH Stability Chambers

Testing - ICH Stability Chamber

  -80°C ± 10°C; Ambient RH

  -20°C ± 5°C; Ambient RH

  5°C ± 3°C; Ambient RH

  25°C ± 2°C; 60% ± 5% RH

  40°C ± 2°C; 75% ± 5% RH

  60°C ± 2°C; 75% ± 5% RH

Additional Support

At Singota, we utilize an Electronic Laboratory Notebook (ELN) to provide our clients with a validated 21 CRF Part 11 data system for all of their analytical test results. Data from method development, QC testing, and R&D projects all is stored in our ELN system.

Contact us with any questions you have about our GMP testing laboratory at –

Learn More About Analytical Testing