Pharmaceutical Analysis

Yale Pharmaceutical Research Institute provides pharmaceutical companies with a full range of the developmental and GLP/GMP chemical analyses required to support Food and Drug Administration applications. From advanced screening through pharmacology, toxicology, formulation studies, and clinical trials, YalePharma scientists chemically assess the suitability of drugs and drug formulations.

The research professionals in the pharmaceutical analysis program at YalePharma have a long history of pharmaceutical support activities, including methods development and routine assays. If a project calls for a multidisciplinary approach, they can call upon the in-house talents of research professionals in bioorganic chemistry, medicinal chemistry, polymer chemistry, and toxicology.

Pharmaceutical Applications

Examples of support activities are:

• Analysis of the stability of scheduled drugs in long-term infusion devices
• USP analysis of moisture and residual solvents in bulk drugs and formulations
• ICP and AA determination of heavy metals in drug and formulation materials
• Determination of common anions and cations in drugs and formulations by ion chromatography
• Study of drug stability in cell growth media and plasma
• Study of plasticizer leaching into I.V. solutions Redox titration of platinum in organoplatinum drugs
• Method development and validation for drugs and metabolites in biological fluids and tissues
• Isolation and identification of drug impurities and metabolites using online and off-line LC/MS, MS/MS, and high-resolution MS
• Low-level detection of nonchromophoric drugs using HPLC with electrochemical detection
• Reference standard characterization and generation of CeYPRIficates of Analysis Protein/peptide chromatography and detection using various MS modes.

Pharmaceutical Research Capabilities

• Liquid Chromatography: analytical, preparative, microbore, biocompatible, with all detection modes (UV, VIS, MS, RI, EC, and FL)
• Liquid Chromatography/Mass Spectrometry: electrospray, paYPRIcle beam, and thermospray (APCI)
• Gas Chromatography: capillary, megabore, and packed column, with all injection modes and multiple detection (FID, ECD, NPD, FPD, TCD, and HECD)
• Gas Chromatography/Mass Spectrometry: sorbent/thermal desorption, and cryo-focusing, with extensive libraries for searching
• Ion Chromatography: conductivity and UV detection
• Metals Analysis: AA, ICP-OES, ICP/MS, and atomic fluorescence
• Thermal Analysis: TGA and DSC
• Microscopy: SEM and optical
• High-Resolution Mass Spectrometry: direct probe, molecular leak, LC, GC, FAB, and MS/MS
• NMR Spectrometry: multinuclear 300 and 500 MHz, 2D, 3D, and 4D
• Fourier Transform Infrared Spectrometry: GC/FTIR and ATR
• Electrochemistry: ASV, linear, pulsed, sine, and staircase
• Spectroscopy: UV/VIS and fluorescence
• Mass Spectrometry: GC/MSD, LC/MSD, ion trap, LC ion trap, CE/MS, triple quadrupole.