R&D Stability Services

Sterin Labs offers a full range of stability service capabilities including ICH, environmental and photostability storage and testing. We meticulously maintain our advanced reach-in storage chambers to ensure optimum precision and security for our customers’ stability studies. Our knowledgeable and accessible staff has extensive experience helping our customers ensure product quality and regulatory compliance through stability storage and testing techniques.

Sterin maintains chambers for conducting both non-GMP and cGMP stability studies in accordance with ICH guidelines. Our stability studies are used to:

  • Determine the robustness of formulation prototypes during early development;
  • Ascertain the chemical and physical integrity of lead formulations prior to advancement into animal/toxicology studies; and
  • Assure final formulations meet stability requirements for prototype formulation batches and scale-up batches.

Sterin conducts stability studies on the parenteral dosage forms manufactured as clinical trial drug products for our clients. The chambers/conditions we test for stability include:

  • On-site stability chambers
  • 40 °C / 75% RH
  • 30 °C / 65% RH
  • 25 °C / 60% RH
  • 5 °C
  • -20 °C and Photostability studies
  • Multiple configurable reach-in chambers
  • Chambers continuously monitored, alarmed, and validated.

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