www.rti.org

Analytical Sciences at RTI International

RTI International offers a comprehensive suite of capabilities that can be leveraged to solve your most challenging analytical problems. Examples include measurements of chemical composition, structure, and morphology; identification of unknowns; and trace analyses. Our experts have decades of experience developing novel and unique methods that can also be brought to bear when new method development and validation are required. We have successfully supported and collaborated with hundreds of public- and private- sector clients, including those in the pharmaceutical and life sciences, personal care, food and beverage, environmental, and oil and gas industries.

The RTI Advantage RTI has a team of more than100 analytical scientists equipped with extensive capabilities built over 5 decades. Areas of expertise include separations, spectroscopy, microscopy, and physical testing. In addition, we understand your need for response within budget constraints and timelines. Analytical Sciences: Custom Solutions to Real-World Challenges Analytical Instrumentation Bioanalytical Method Development, Validation, and Application • Chromatography and separations (HPLC, UPLC, GC, IC, CE) with Our scientists develop, validate, and apply GLP various detectors methods for bioanalysis of foods, cosmetics, and pharmaceuticals. • GC-MS (standard, MS/MS)

• LC-MS (MS/MS, high-resolution, ion mobility)

• Phase imaging and identification by optical microscopy (stereomicroscopy and PLM), electron microscopy (ESEM, TEM), AFM, and XRD

Analytical Support for Clinical Trials • Elemental analysis (ICP-OES, ICP- MS, SF-ICP-MS, EDXRF, EDX) RTI routinely develops, validates, and applies analytical methods to support clinical trials. • Physicochemical characterization (particle counting, DSC and MDSC, TGA)

• Spectroscopy (NMR, FTIR, Raman, CD, fluorescence, energy dispersive, polarimetry, refractometry)

• Particle sizing (SEC, laser light diffraction, DLS, MALS, optical and electron microscopy) Medical Device Development • Moisture analysis RTI provides comprehensive analytical support (Karl Fischer, GC-MA) to the development of sustained- release delivery systems of antiretrovirals in support of • Dissolution and women’s health. disintegration testing

• Sample preparation (class 100 clean hoods, contamination- controlled facilities)

• Monitored cold storage and environmental stability and photostability chambers Proficiency Testing and Contamination Control Synthesis and Characterization Industrial Hygiene of Metabolites

We ensure the competence of other laboratories RTI routinely provides measurements to control RTI regularly synthesizes and characterizes through RTI-administered programs such as contamination in the automotive, semiconductor, metabolite standards required for metabolomics the AIHA Beryllium Proficiency Analytical and pharmaceutical industries. analysis and utilizes broad-spectrum and targeted Testing Program. methods to analyze metabolites.

Vaccine Characterization USP Elemental Impurity Analysis Complex Chemical Characterization

RTI provides analytical services to determine Our scientists work with industry collaborators RTI provides time-critical support for multiple various constituents in vaccines in support of to address analytical challenges around metal product safety studies for commercial clients in Investigational New Drug (IND) applications. contaminants in drug products and ensure compliance with GLP and EPA FIFRA regulations. regulatory compliance with USP <232>/<233>.

Novel Biopesticides Industrial Troubleshooting Specialty Formulation

RTI collaborates with agricultural researchers RTI determines the source of visible contamination RTI’s Materials Handling Facility serves as a GLP to discover novel biopesticides for in pharmaceuticals and other products. chemical repository to aliquot and ship samples sustainable agriculture through advanced worldwide. The facility also provides support for analytical characterization. GLP toxicology studies with feed diet, gavage, drinking water, and IV formulations. RTI’s numerous accreditations are evidence of our robust determination of particulate matter and trace metals in quality systems and adherence to established U.S. and ambient air. LELAP Certificate #04017 international quality standards. • Accredited reference materials producer—ANSI-ASQ Sample Accreditations National Accreditation Board (ANAB) accreditation as CCR P A ED a reference material producer under ISO Guide 34:2009 AAP IT LL E EE D NN for drugs in urine, oral fluid, and serum.

A • ANAB Certificate #AR-1984 Y C TNI CL D A O REB R BY DOITRAATITOON • In addition, our familiarity and compliance with regulatory requirements, such as GLP and cGMP/GMP, engenders confidence in our analytical data. Accredited for analysis of IH metals, environmental lead, respirable silica, and asbestos. More Information [email protected] RTI International • Accredited air emissions laboratory—Louisiana 3040 E. Cornwallis Road Environmental Laboratory Accreditation Program/ Park, NC 27709-2194 USA National Environmental Laboratory Accreditation www.rti.org Program (LELAP/NELAP) accreditation for the RTI 9696R5 0319

Selected Clients Industry and Commercial Clients • State University Foundations and Associations • The Education Trust • Abbott Laboratories • NC State Industry Expansion Solutions • AANA Foundation • The John Merck Fund • Ardelyx, Inc. • Princeton University • American Beverage Association • The MITRE Corporation • Aronora, Inc. • Purdue University • American Board of Pediatrics • The Water Research Foundation • Ascend Performance Materials • Queens College • American Industrial Hygiene Association • Walton Family Foundation • Aurecon AMEI Limited • St. John’s University • Bill & Melinda Gates Foundation • Biogen • Stanford University • CDC Foundation State and Local Governments • Boston Scientific Corporation • University of Chicago • Children’s Investment Fund • California Governor’s Office of Planning and Research • Bruce Power – Canada • University of Michigan Foundation – UK • Florida Department of Health • Chevron Energy Technology • University of North Carolina at • Citi Foundation • North Carolina Division of Adult • Gardenia Blue Interest Chapel Hill • City Year, Inc. Correction and Juvenile Justice • Nestec, Ltd. Switzerland • University of North Carolina System • ConnectEd • New York City Department • University of Nebraska Omaha • Health System • Newell Rubbermaid of Health • University of Pittsburgh • Evidence Action • Nielsen • New York State Department of • PTC Therapeutics, Inc. • University of Southern California • Fairbanks Foundation Environmental Conservation • San-Ei Gen F.F.I., Inc. • Virginia Tech • George Lucas Education Foundation • State of Louisiana • Syngenta Crop Protection • Wake Forest University • Global Alliance for TB Drug Development • State of New York • Talisman Environmental • Gordon & Betty Moore Foundation • Wyoming Water Development • The Hershey Company U.S. Government • Kansas Health Foundation Commission • Consumer Financial Protection Bureau • U.S. News & World Report • Living Cities • Department of Agriculture • MacArthur Foundation Multilateral Donors Colleges and Universities • Department of Commerce • MassMEP and International • Arapahoe Community College • Department of Education • Medtronic Global Health • Department of Energy Government Agencies • Colorado State University • NAPE Education Foundation • Daegu Catholic University • Department of Defense • Columbia University • National Council on Aging Foundation • Department of Health and Human • Duke University • North Carolina Chamber • Dubai Health Authority Services • Georgia Institute of Technology • Patient Teacher Home Visit • Department of Foreign Affairs and • Department of Homeland Security • Harvard University • PCORI Trade – Australia • Department of Justice • Icahn School of Medicine at Mount Sinai • REDF • Environmental Agency – Abu Dhabi • Department of State • Iowa State University • Robert Wood Johnson Foundation • Imam Abdulrahman Bin Faisal • Department of the Interior • Johns Hopkins University • Rockefeller Foundation • Inter-American Development Bank • Department of Transportation • Mississippi State University • Share Our Strength (SOS) • The World Bank • U.S. Agency for International • Montana State University • The Aspen Institute • UNICEF – Tanzania Development • North Carolina Central University • The College Board

RTI International is an independent, nonprofit research institute dedicated to improving the human condition. Clients rely on us to answer questions that demand an objective and multidisciplinary approach—one that integrates expertise across the social and laboratory sciences, engineering, and international development. We believe in the promise of science, and we are inspired every day to deliver on that promise for the good of people, communities, and businesses around the world. For more information, visit www.rti.org.

RTI International is a registered trademark and a trade name of Research Triangle Institute. The RTI logo is a registered trademark of Research Triangle Institute.