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Analytical Methods:Development, Validation, Optimization, Transfer
PharmaCore offers comprehensive analytical methods support performed by an experienced staff of skilled analytical scientists.
We can develop methods using a wide range of analytical techniques as well as assist in the design of validation protocols based upon your requirements. We are available for analytical consulting as required.
We can validate or revalidate methods you are presently using to help ensure accuracy and reliability in your analytical processes. Validation protocols can be supplied by you or written by us using our validation templates.
PharmaCore's scientists have specialized expertise in optimization/improvement of analytical methods. Whether the purpose is just to update an older method or to help shorten your analytical testing cycle time while decreasing your analytical costs, let us help you reach your goals.
We also have the capability to directly transfer methods from our facility to one of your choosing, or to function as an intermediary or facilitating lab in a multi-location method transfer process. We can use our protocols or yours in these activities.
We can perform forced degradation studies on your drug substance or drug
product to provide you with stability-indicating analytical procedures. Routine forced degradation at PharmaCore is done using acid, base, peroxide, heat,
and light.
The analytical techniques we use to develop and validate methods are:
Detailed procedures and results for all method development and method
validation projects are presented in a comprehensive report. Our report format
includes a copy of the analytical method, protocols when applicable, all test
results, appropriate graphs and calculations, and sample raw data (such as chromatograms). The report can also be prepared to client specifications and format. In addition, we can deliver the report on CD along with the standard bound copy.
We will contact you to discuss any analytical problems or results that seem unusual. We encourage your close review of the data we generate on your project.
PharmaCore's scientists bring a wealth of real-world experience to the table to help meet your needs. Our analytical operations are based on written, detailed SOPs and stringent quality assurance practices, and all of our work is performed in compliance with cGMP requirements.
We welcome client visits or audits to review our standard operating procedures,
to verify our strict compliance with current GMPs, and to demonstrate our
experience in analytical methods support.
For more information on our analytical methods support capabilities or any of our pharmaceutical capabilities, please call PharmaCore at 336-841-5250, extension 159 (Mark Shapiro, Director GMP Analytical) or extension 101 (Kelly Tilyard, Marketing Manager).
