Contact Us
 

Method Development & Validation

A core focus on analytical services.

At Metrics Contract Services, analytical services are the backbone of our company. With over 90 analytical chemists on staff — that’s four chemists for every formulator — and extensive equipment, you can be assured that there will never be a bottleneck in the analytical department.

Always looking ahead.

Methods are developed at Metrics Contract Services with future validation, transfer, and ease-of-use in mind. Seamless scale-up is a priority and we are always considering the next phase or the commercial production needs of a product. We will work with you to develop a validation plan to meet the specific regulatory requirements of your product.

Validation for every step.

Metrics Contract Services offers various levels of method validation from abbreviated qualification (specificity, linearity, accuracy, etc.) to support early-phase studies to full ICH-compliant validation for late-phase and commercial products (robustness, ruggedness, reproducibility, etc.).

Unique compounds.

Metrics Contract Services has experience with a wide range of unique and specialized compounds:

  • Potent
  • Toxic
  • Light-sensitive
  • Temperature-sensitive
  • DEA Scheduled II-V controlled substances
  • Other challenging molecules

A range of dosage forms.

Metrics Contract Services specializes in developing dissolution and drug release procedures for a wide range of dosage delivery systems including:

  • Tablets
  • Capsules
  • Suspensions
  • Transdermals
  • Raw materials and excipients

Metrics Contract Services is well known for dissolution and HPLC capabilities. Our expertise in this area allows us to support all areas of formulation development.

Experienced leadership, extensive instrumentation.

Metrics Contract Services analytical group leaders are highly experienced – many with decades of laboratory operations under their belt. As a Metrics Contract Services client, you will work directly with these group leaders, who are empowered to solve problems throughout the process. Metrics Contract Services’ state-of-the-art, fully qualified cGMP facility features a broad and diverse set of instrumentation to solve your analytical problems while meeting critical timelines.

Analytical Testing Capabilities

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

 

“Understanding the regulatory and market demands of the business is the cost of entry. We want to stay one step ahead by developing the right validation plan from the beginning.”

— Tracy Baker