Saturday, May 18, 2024



Stability Testing

Biomedical Devices often require accelerated Hydrolytic Stability Studies to predict their long-term in situ performance.  Hydrolytic stability studies typically include immersion of the device, or coupons of the material(s) used in the construction of the device, in buffered saline and incubation at elevated temperatures.  After prescribed durations of incubation the devices (materials) are recovered for microscopic imaging/functional testing and the supernatants are chemically analyzed for evidence of degradation.  Temperatures as high as 100°C have been used in some cases.  Arrhenius kinetics is used to correlate the elevated incubation durations to real-time in situ exposure times.

Ophthalmic devices, as well as other devices/components that might be light sensitive, are investigated in accelerated Photo-stability Studies in which device or material samples are exposed to high levels of UVA or visible light for a pre-determined period of time.  Photo-exposure mathematical models are used to correlate laboratory exposure durations to real-time in situ exposure times.  Following recovery, devices (materials) are evaluated microscopically and functionally and supernatants are chemically analyzed for signs of degradation.

Shelf Life Studies constitute a third group of stability evaluations.  Final product (device, drug, personal care product, etc.) in final packaging, is incubated both at real-time storage temperature and at elevated temperatures for accelerated aging.  At recovery points, product is evaluated physically and chemically for signs of degradation/loss of potency or functionality.  Solid materials can be extracted or dissolved and the resulting solutions/extracts analyzed chemically for degradants.  Drug or personal care preparations can be analyzed directly or upon dilution in appropriate solvents for retention of the active ingredients and the presence of degradant species.

Mass Spec Lab has the protocols and equipment to perform all groups of stability studies on medical devices, active pharmaceutical ingredients (APIs), final drug products, personal care products, etc..  Our UPLC/PDA-UV/QTof-MS and APGC/QTof-MS capabilities allow sensitive selective detection of active ingredients, contaminants, and degradants.  These techniques are uniquely qualified for identification and quantitation of unknown species in the supernatants of aged samples.

In addition, the scientists at Mass Spec Lab take special pride in working closely with clients to assure that experimental protocols, results and final reports from our stability studies are accurate, concise, and well-targeted relative to internal or external submission requirements.

We can help you design and execute effective stabiliy protocols. Request more information or call us at 949-872-2724.

How To Submit Samples