Analytical Services

Our cGMP analytical laboratories located in Wilmington, NC and Neu Ulm, Germany have almost 30 years of experience in providing analytical support for product development and manufacturing programs. The analytical organization is structured into groups with specific focus on:

Small Molecule

Biopharmaceuticals

Compendial Testing

Over the years the analytical organization has grown in size and has developed robust and time-tested operational and compliance systems. Our current scientific staff of over 240 occupies over 75,000 square feet of space with approximately 120 state of the art HPLCs with a variety of detection techniques, a full array of mass spectroscopy systems, AAA, CE and numerous other techniques and systems all at your disposal. Our scientific staff includes 14 Ph.D. scientists, over 35 scientists with M.S. degrees and many highly skilled B.S. level chemists with 10+ years of experience who have acquired extensive experience and expertise working with a wide range of pharmaceutical APIs and drug products including both large and small molecules.

AUTOMATED QUOTE GENERATOR FOR RAW MATERIALS!

MERCURY
AAIPharma's Compendial Testing Laboratory automated quote generation system is a web portal that allows you the opportunity to generate your own raw material and microbiology testing Service Estimates. The system is simple, fast and accurate and provides flexibility over the quote generation process.

Our staff has experience with a variety of synthetic and biopharmaceutical compounds (APIs), finished product dosage forms and delivery systems such as tablets, capsules, soft gel capsules, pellets, parenterals, lyophilized products, suspensions, emulsions, creams, ointments, trans-dermal systems, medical devices and medicated feeds. We have expertise in a broad range of analytical techniques and types of equipment. AAIPharma develops analytical methods for drug substances, intermediates and drug products for batch control and stability testing as well as for new drug applications/registrations. Types of analyses include identity, purity, content and dissolution assays according to different registration requirements, CPMP/ICH regulations and customized requests. A variety of cleaning methods (swab or rinse sampling techniques, using a UV, GC or HPLC test methods) can also be developed to support the manufacturing environment. Residual active and cleaning agent testing is also available. Validations are conducted according to a written protocol pre-approved by the customer and AAIPharma before project initiation.

At AAIPharma, our analytical labs are an extension of your organization and it is our goal to provide the highest service levels in the industry no matter what the size of the project.