Testing

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
• 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

• -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

At Singota, we utilize an Electronic Laboratory Notebook to provide access for our clients to GMP 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. Contact us with any questions you have about our GMP testing laboratory or other analytical testing services. This system provides communication between our clients and our team that is protected, risk-free, and simple to use. Contact us with any questions you have about our GMP testing laboratory.