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.