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 capabilities to those in need, with a specialty in parenteral product testing.

Singota Solutions provides extensive CDMO analytical testing services tailored to meet the evolving needs of the pharmaceutical industry. Leveraging our expertise in small batch aseptic filler technology, aseptic manufacturing, and injectable formulation development, we deliver high-quality solutions customized to our clients’ specific requirements. Our cGMP services cover a broad spectrum of critical test areas, including GMP, material identity verification, in-process, product release, and product-specific assays. We specialize in the following test services, including compendial, microbial (including endotoxin, bioburden, and sterility), CoA generation, ICH stability under all ICH conditions, retention sample management, inspection, in-use infusion studies, container closure integrity, forced degradation, transportation, 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 test services throughout the drug development process.

GMP analytical services include:

Analytical Testing Request Form

     

    ICH Thermal Stability Test Programs

    Compound

    Raw material for manufacturing use

    Release and CoA generation

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

    Cytotoxic compounds

    Thermal Cycling and Excursion

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

    Captisol®

    Microbial (Sterility, Endotoxin & Bioburden)

    Container Closure Integrity

    Singota Solutions Testing Testing machine Singota
    Singota Solutions Testing Testing uhplc

    ICH Stability Chambers

    Testing ICH Stability Chamber 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

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    At Singota, we utilize an Electronic Laboratory Notebook (ELN) to provide our clients with a 21 CFR Part 11 compliant 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 services at: solutions@singota.com