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Stability Testing and Services |
Integrated Analytical Laboratories, LLC (IAL) offers a comprehensive array of Stability
Storage and Testing services. IAL is well versed in ICH, cGMP, and GLP guidelines.
Expertise in analysis along with state-of-the-art instrumentation enables us to
devise studies that will not only meet labeling and regulatory requirements but will
also be cost effective.
Our in-house storage is comprised of environmental stability chambers that operate
independently and have individual temperature and humidity controls.
All chambers are continuously monitored by a Rees Back-Up System
(hardwired security system) and back up generators are used to prevent
loss of power. It is critical that the chambers are never compromised.
Stability indicating methods are either developed in house or supplied by our clients.
All client supplied methods are transferred and validated. IAL also conducts feasibility
studies as a cost effective measure for the client, and the feasibility studies are
typically completed within 2 to 5 days. Once the feasibility study is completed,
the stability indicating method is developed or transferred.
IAL will issue a tabular report to the client at each time interval. All reports are
cumulative and issued within 8 to 10 days of the sample pulls. We will also
customize reports to meet individual client specifications and we are able to
provide reports in an electronic format.
Stability Chamber Conditions:
Ambient Temperature
Accelerated Conditions (40°C / 75%RH)
Intermediate Conditions (30°C / 60%RH) or new ICH guideline
Long-Term Conditions (25°C / 60%RH)
Stability Sample Testing
Stability testing for a drug substance and drug product including impurities.
Stability testing for cosmetics
Finished Product Release
Comparator Stability Testing
Formulation Evaluation Stability Testing
Residual Solvents
Dissolution
Photostability - Forced degradation
Please call our Pharmaceutical and Cosmetic Testing Business Development Department
at 973-361-4252 for more information regarding our stability services.
You can also contact us via email at pharminfo@ialonline.com.
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