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Routine Testing Services

The Expertise to Handle Sample Analysis for Any Pharmaceutical Development Project

Metrics Contract Services analytical laboratory services team is an integral part of helping our clients with their pharmaceutical development projects but many of our clients rely on us for being their external laboratory. Each day our over 100+ analytical scientists are performing routine testing of samples for release of drug substance or drug product, testing of samples from experiments conducted during development, or samples pulled from stability studies. Our scientists use a wide range of methodology to conduct this work.

Following is a detailed look at our comprehensive services.

High Pressure Liquid Chromatography (HPLC)

  • Stability-indicating gradient HPLC methods for drug substances and drug products
  • Isocratic HPLC methods to support nonstability-indicating tests (Dissolution, Content Uniformity)
  • Development of rapid UPLC methods including conversion of traditional methods to UPLC
  • Chiral, Gel Permeation, Reversed-phase, Normal-phase, Ion-pairing, and Ion Exchange separations
  • Forced degradation studies
  • UV/VIS (including PDA), Refractive Index, Evaporative Light Scattering, and Mass Spectroscopic detection
  • Agilent 6530 Accurate Mass Q-TOF equipped with ESI and APCI for MS and MS/MS analyses

Gas Chromatography (GC)

  • Residual Solvents methods (compendial and non-compendial) for drug substances, raw materials, and drug products
  • Assay methods for non-solvent volatile impurities and intermediates
  • Headspace and direct injection sample introduction for packed and capillary columns
  • Flame Ionization (FID), Thermal Conductivity (TCD), and Mass Spectroscopic (MS) detection

Ion Chromatography (IC)

  • Analysis of inorganic cations and anions; organic acids and bases; as well as amino acids and proteins
  • Analysis of mono-, di-, oligosaccharide, polysaccharide and their derivatives
  • Multiple Dionex Ion Chromatographic HPLCs available with Conductivity and Amperometric detection

Karl Fischer Moisture Titrations

  • Moisture testing of powders, capsules, tablets, suspensions, liquids, and lyophilized products
  • Volumetric titration instrumentation including units with homogenizers for analysis of tablets and capsules
  • Coulometric titration instrumentation for low-level moisture determinations
  • Drying oven sample introduction and/or Ketone-specific reagents for difficult sample matrixes

Particle Size Characterization

  • Malvern Mastersizer S (Laser Diffraction) with Wet or Dry Dispersion options
  • Malvern Zetasizer Nano ZS (DLS)
  • Olympus BX51 Polarized Light Microscope (Optical Microscopy) with a DP71 Digital Camera

Dissolution and Drug Release

  • Water soluble, sparingly water soluble, toxic, potent, DEA-regulated, and unstable compounds
  • Capsules, tablets, enteric coated tablets, suspensions, chewables, and transdermal patches
  • Immediate release and modified release formulations
  • Single medium dissolutions, 2-stage dissolutions, 12- and 24-hour dissolutions
  • Intrinsic dissolution testing and dissolution media mapping
  • Comparative studies – overencapsulated commercial tablets and capsules
  • Apparatus 1, 2, 3, and 5; manual or automated sampling
  • UV/VIS and HPLC analysis options

Other Analytical Techniques

  • Differential Scanning Calorimetry (DSC) and Thermal Gravimetric Analysis (TGA)
  • UV/VIS, TOC, Viscometer, Polarimeter, Refractometer, Osmometer, Fluorometer, FTIR, pH, TLC, Ion-selective Electrodes, Potentiometric and Colorimetric Titrations
  • As part of our Pharmaceuticals Development services, Metrics does provide in-house Raw Material, Microbiology, and Elemental Impurities analysis.*

* - these tests are not offered as standalone testing services by Metrics Contract Services.