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What are Stability Studies?
According to the FDA “the purpose of stability testing is to provide evidence on how the quality of a drug substance or drug product varies with time under the influence of a variety of environmental factors, such as temperature, humidity, and light, and to establish a retest period for the drug substance or a shelf life for the drug product and recommended storage conditions.” In other words, stability testing evaluates how a drug breaks down over time under a variety of conditions. In general, most stability storage testing is performed according to ICH guidelines. Often, extreme conditions are used to accelerate stability programs. These stressed conditions enable data to be generated more quickly which expedites the development process. Ultimately, the data generated is used to determine how long the drug maintains its therapeutic effect and if any found degradants are potentially hazardous if ingested.
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Stability Studies at EKG Labs
EKG Labs provides stability study support services for combination medical devices and pharmaceutical products. We often performed stability analysis within a broader extractables and leachables study. EKG Labs can develop and validate stability indicating assays that support both long-term and short-term stability studies. Our stability services include:
Material Experience for Stability Studies
- APIs and Drug Substances
- Finished Drug Products
- Clinical Trial Material
- Solid Dosage Forms (tablets, capsules, etc.)
- Liquid Dosage Forms (injectables, suspensions, etc.)
- Topical Dosage Forms (creams, ointments, etc.)
- Container Closure Systems and Combination Products (pre-filled syringes, MDIs, etc.)
- Medical Devices (implants, pumps, etc.)
Analytical Techniques for Stability Studies
- Chromatography – HPLC, LC/MS, GC/MS, GC/FID, GC/TCD, GPC/SEC
- Spectroscopy – ICP-MS, NMR, MS, PXRD, TF-XRD, UV-Vis, FTIR, Raman
- Microscopy – SEM, TEM, AFM, STM, LSCM
- Other- TGA, DSC, TOC, BET Surface Area/Pore Size Analyzer
