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Primera Analytical Solutions Corp

259 Wall Street

Princeton, NJ US

Primera Analytical Solutions, in Princeton, NJ, is a contract laboratory featuring modern equipment, a dynamic team of experienced scientists, and an outstanding quality system meeting rigorous GLP standards of documentation demanded by the pharmaceutical industry. With over 6500 square feet of laboratory space, the Primera laboratory has capabilities in LC/MS/MS, GC/MS, HPLC analysis, featuring an array of modern instruments, including API 4000 instruments, Micromass Ultima instruments, Agilent GC/MS, and Agilent, Shimadzu, and Waters HPLC systems. Also available are variety of other advanced scientific instruments, including IR, UV, dissolution equipment and other analytical equipment. We have in house formulation capability as well. All of the instruments are maintained with a GLP system of IQ/OQ/PQ data, instrument logs, and a system of SOP's for sample handling, preparation, and data that assure reliable and traceable data of the highest quality. Founded by scientists experienced in complex chemical analysis of analytes in biological matrices, Primera brings a broad set of capabilities to support pharmaceutical programs through the development process. Lead by Bibo Xu, who brings more than 15 years experience in major corporations and contract laboratories, the company is poised for fast growth in partnership with its clients. The professional development team is evenly divided between Ph.D., M.S. and B.S. scientists with the experience to manage difficult and demanding projects. Maintaining strict dedication to meeting timelines and providing data that supports development programs in all phases of projects, Primera is a focused, dynamic company with whom small and medium and large companies can co-operate on projects that succeed scientifically and commercially and in a timely and professional manner.

Technical Information:

Pharmaceutical Formulation, Preclinical /Phase I Formulation, Preformulation Studies, Formulation Screening, Dissolution Methodologies, Stability Issues, Bioavailability Enhancement, Novel Drug Delivery Generic Product Development, Compound Management QC, Bio-Analytical, Method Development, Metabolism, Pharmaceutical, AgroChemical, Biotechnology, Pharmacokinetics and Toxicokinetics, Analytical support for drug metabolism studies, Animal tissue and biological fluid analysis, In vitro plasma protein binding (ultrafiltration and equilibrium dialysis) using cold assay Metabolic stability based on parent disappearance in in vitro metabolism media including liver microsomes, S9, and plasma from animal species and human, c-DNA expressed Supersomes for human, gastrointestinal fluids, and other specific matrices per customer request (such as lung microsomes for inhalation compound) In vitro metabolic clearance determination: in vitro/in vivo extrapolation Preliminary enzyme mapping: in vitro metabolism with or without general or specific CYP inhibitors based on parent disappearance to examine the overall CYP contribution and specific CYP isoforms CYP inhibition potential (IC50): 3A4, 1A2, 2C9, 2C19, 2D6 using standard probe substrates Cold Profiling: identification of major metabolites and metabolic pathways from cold in vitro or in vivo studies Identification of metabolic softspot based on metabolite structure identification Bioanalytical method development and validation in plasma, urine, and other biological matrices in pharmacological or toxicological animal species or humans Bioanalytical sample analysis in plasma, urine, and other biological matrices Our instrumental capacity includes:

Triple quadrupole LC/MS/MS Agilent GC-MS Packard 500 TR Flow Scintillation Analyzer Agilent HPLC System, Raw materials, API, finished products, dosing solutions Chiral separation Drug substance impurity profile Cleaning validation Dissolution testing (USP Apparatus I and II) Stability indicating method and assay Pre-clinical and clinical studies Bioequivalence Full sample management service Stability study (25°C/60% RH, 30°C/65% RH, and 40°C/75% RH)

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