Singota performs GMP analytical testing services including ICH stability test programs and raw material testing for manufacturing release/CoA generation


Our Capabilities:

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. Analytical testing services include:

  • ICH Thermal Stability Test Programs
  • Compendial Testing
  • Raw material testing for manufacturing use
  • Release and CoA generation
  • Trials for Solubility, pH, Degradation, Potency, Purity, Reconstitution
  • Testing of cytotoxic compounds
  • Thermal Cycling and Excursion Testing
  • Materials Compatibility Testing (e.g.: infusion sets, IV bags, stoppers, etc.)
  • Packaging and container component physical inspections

ICH Stability Chambers

  • -80 +/- 5 °C; Ambient RH
  • -15 +/- 5 °C ; Ambient RH
  • 5 +/- 3 °C ; Ambient RH
  • 25 +/- 2 °C; 60 +/- 5 % RH
  • 40 +/- 2 °C; 75 +/- 5 % RH
  • 60 +/- 2 °C; 75 +/- 5 % RH

Additional Support

At Singota, we utilize an Electronic Laboratory Notebook to provide access for our clients to testing data, results, and reports as we complete assays and post results. This system provides communication between our clients and our team that is protected, risk-free, and simple to use.

Let's discuss how we can support you and your projects

Contact Singota