Research and Development Support
Testing support for product research and development.
Impact Analytical provides analytical testing to support drug product and medical device research and development. Impact’s scientists have a combined 300+ years of experience in analytical chemistry. We have experience developing material specific assays and methods for use in research support that can subsequently be utilized for final product testing. Our dedicated R&D support teams partner directly with the client to provide chemical and material testing support that ensures timeline integrity. This approach allows the client to access our experience and regulatory knowledge directly, saving time and budget.
Impact Analytical provides focused support for API development, assay and impurities methods development, container closure material selection, stability, drug or material compatibility, dissolution, extractables, accelerated stability, and medical device material selection. This support can be leveraged from development through preclinical, phases I and II, and final product manufacture.
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Analysis for Extractables & Leachables from Pharmaceutical container closure systems and single-use processing equipment as well as Medical Device such as implantables and infusion systems.
A critical step in the development of a new pharmaceutical product or medical device is the assessment of Extractables & Leachables (E&L). Chemicals can leach into drug products or patients through the materials used to construct manufacturing equipment, devices or primary and secondary packaging. These leachables can include monomers, oligomers, additives, stabilizers, residual solvents, metals, fillers, dyes, pigments, and catalysts.
Impact Analytical has extensive polymer characterization experience. This experience is
- Fully characterize the packaging, processing equipment, and devices
- Design and conduct appropriate extractables studies that will identify probable leachables
- Validate methods for these targeted compounds
- Conduct both accelerated and real-time leachables studies
- Correlate the leachables to the extractables and identify their source
- Design and conduct routine extractables testing to ensure a consistent supply chain for new batches of container closure systems, manufacturing equipment, and devices
- Provide Toxicological Assessments for all extractables and leachables
Impact Analytical is a cGMP compliant laboratory that has been recently audited by the FDA, with no 483’s issued. All study design and E&L testing is performed according to the latest industry recognized “best practices” including the United States Pharmacopeia (USP), Product Quality Research Institute (PQRI), Bio-Process Systems Alliance (BPSA), and ISO-10993.
Impact Analytical utilizes state-of-the-art laboratory equipment to detect, identify, and quantitate all extractables and leachables. These instruments include:
- Fourier Transform Infra-red Spectroscopy (FT-IR) for material characterization
- DSC and TGA for polymer characterization
- Traditional extraction methodologies – Soxhlet, sonication, agitation
- Accelerated Solvent Extraction (ASE)
- Headspace GC-MS for volatiles
- GC-MS for volatile and semi-volatile organics
- LC-MS, including exact mass for semi- and non-volatile organics
- ICP-MS for trace metals, inorganics
- Ion Chromatography for inorganics
Extractables and Leachables Testing for Medical Applications
July 25, 2014
By: Michael Ruberto, Ph.D.