Analytical and Stability Testing for Injectable Development

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    • Analytical and Stability Testing for Injectable Development

    Comprehensive In-House Analytical Capabilities

    Oakwood Labs provides a full suite of in-house analytical testing capabilities  to support both formulation development and clinical supply manufacturing. By keeping these capabilities internal, we offer rapid turnaround on results and close collaboration between analytical and formulation teams, ensuring faster problem-solving and more efficient formulation development.

    Our fully equipped laboratories are located within both the R&D facility and the GMP facility, and include quality control chemistry and microbiology labs. Our expertise spans the entire analytical lifecycle: from initial method development to full method validation for Phase III clinical trials and commercial production, all conducted to globally harmonized standards.

    In addition to analytical testing and method development, Oakwood Labs performs ICH-compliant stability studies, covering accelerated, intermediate, and long-term conditions, to ensure product quality throughout shelf life.

    For the development of microsphere-based products, our typical characterization analysis focuses on four key tests, designed to optimize performance, stability, and release profiles:

    Analysis Method
    Drug Load (% drug encapsulated) HPLC Assay
    Particle Size and Volume Distribution Laser Diffraction
    Residual Solvent Gas Chromatography
    In Vitro Release Shaker Bath or USP II/IV Apparatus, HPLC Assay

    Full Range of Analytical Testing Capabilities:sustained release drug delivery

    • HPLC/UPLC
    • GC
    • GPC
    • In vitro dissolution
    • Laser diffraction particle sizing
    • Differential Scanning Calorimetry (DSC)
    • Karl Fischer moisture (KF)
    • Scanning electron microscopy (SEM)
    • Non-destructive oxygen headspace
    • UV/Vis
    • pH
    • LC/MS (external)
    • GC/MS (external)
    • NMR (external)

    Whether you have limited methods developed for your product or fully validated methods, Oakwood can assist. Reach out to our team today to learn how we can initiate a seamless method transfer and begin developing robust analytical methods with quick turnarounds for your product.