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.

Singota Solutions provides extensive CDMO testing services tailored to meet the evolving needs of the pharmaceutical industry. Leveraging our expertise in small batch aseptic filler technology, aseptic manufacturing solutions, and injectable formulation development, we deliver high-quality testing solutions customized to our clients’ specific requirements. Our cGMP testing services cover a broad spectrum of critical areas, including GMP testing, material identity verification, in-process testing, product release testing, and product-specific assays. We specialize in compendial testing, microbial testing (including endotoxin, bioburden, and sterility testing), CoA generation, ICH stability testing under all ICH conditions, retention sample management, inspection, and testing, in-use infusion studies, container closure integrity testing, forced degradation testing, transportation testing, as well as method validation, qualification, development, and transfer services. With our unwavering commitment to excellence and strict adherence to regulatory standards, Singota Solutions is your trusted partner for reliable and efficient testing services throughout the drug development process.

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

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ICH Stability Chambers

Testing ICH Stability Chamber Testing ICH Stability Chambers 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:

Learn More About Analytical Testing