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Primera Analytical Solutions Corp

259 Wall Street

Princeton, NJ US

Primera Analytical Solutions Corp Services:

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)