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.)
Captisol® Testing
Microbial Testing ( Sterility, Endotoxin & Bioburden)
Container Closure Integrity Testing
ICH Stability Chambers
-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 – solutions@singota.com