Product/Service

Analytical Method Development & Validation

Source: Metrics, Inc.

development and validation image

Metrics supports its pharmaceutical development services with a team of over 130 analytical chemists. In addition to analytical method development and validation, Metrics also offers microbiological testing, stability storage and testing, raw material release, trace element testing, and routine analysis of dosage forms and drug substances.

Click Here To Download:
Brochure: Analytical And Microbiology Services
Brochure: Analytical Equipment List
Brochure: Metrics' Contract Pharmaceutical Development Laboratories Capabilities

Metrics, Inc. method development and validation services has a veteran staff with state-of-the-art laboratories and equipment. Metrics has potent and toxic capabilities and intuitive approaches to poorly soluble and complex compounds. With complete, quality systems in place you're assured analytical methods that are practical and transferable.

The Metrics Difference

  • A veteran staff
  • State-of-the-art laboratories and equipment
  • FDA and DEA registered and inspected
  • Intuitive approaches to poorly soluble and complex compounds
  • DEA II-V
  • Potent and toxic capabilities

 

What It Means For You

  • Your most aggressive timeline will be met.
  • You’re assured of analytical methods that are practical and transferable
  • Your point of contact is an industry veteran from whom you’ll receive one-on-one consultation.
  • Complete, quality systems in place
  • Competitive pricing

 

Dosage Forms:

  • Tablets
  • Capsules
  • Suspensions
  • Transdermals

 

 

Wide range of compounds handled:

  • Potent
  • Toxic
  • Light–sensitive
  • Temperature–sensitive
  • DEA II–V
  • Other challenging molecules

 

Metrics, Inc. Analytical Methods Development & Validation services provides various levels of method validaton — from abbreviated qualification to support early–phase studies to full ICH–compliant validation for late–phase and commercial products.

Method Development and/or Validation for:

  • Chromatography (LC and GC)
  • Dissolution (UV and LC finish)
  • Moisture (Karl Fischer)
  • Particle Size (Malvern)
  • Ion Chromatography (Dionex)
  • AA/ICP
  • FTIR
  • Titrations
  • Particulate Matter (HIAC)
  • Cleaning Methods (LC and TOC)

 

Analytical Equipment List (quantity/type)

  • 117 HPLC systems (Agilent 1200 and Hitachi Elite 7000 Gradient HPLC Systems, Dionex ICS-2500 IC Systems, Waters 2695, Shimadzu LC-2010 CHT)
  • LC/MS Agilent 6530 Accurate Mass Q-TOF, Equipped with Jet Stream Focusing, ESI and APCI for MS and MS/MS Analyses
  • 15 GC systems (Perkin Elmer Clarus and Agilent 6890 GC’s, and an Agilent 6890 GC with 5975 MSD.)
  • 7 UV/VIS Spectrophotometers
  • Dissolution Baths (USP Apparatus I, II, III, and Intrinsic Dissolution: 23 Manual sampling, 6 Automated sampling

 

Microbiological Equipment/Services:

  • Sterility (Equinox Steritest)
  • BET (Pyros Kinetix Turbidimetrics Sytem and Gel–Clot)
  • Particulate Matter (Light Obscuration (HIAC) and Optical Microscopy)
  • Water Testing (Milliflex Pump System)
  • Microbial Enumeration Tests and Tests for Specified Microorganisms per Harmonised USP <61> and <62>.
  • Antimicrobial Effectiveness
  • Antibiotic Assay—(Cylinder Plate Analysis)
  • Environmental Monitoring

 

Other Analytical Equipment/Services:

  • TLC (with photo documentation)
  • FTIR
  • Titrations (colorimetric and potentiometric)
  • pH
  • Karl Fischer (volumetric, blending volumetric, and coulometric)
  • Atomic Absorption (AA) — Flame, Graphite Furnace, and Cold Vapor
  • Atomic Emission (AE)
  • Inductively Coupled Plasma (ICP)
  • Viscometer, Polarimeter, Refractometer, Osmometer, Fluorometer
  • TOC
  • Laser Diffraction Particle Size (Malvern Mastersizer S)
  • Dynamic Light Scattering (Malvern Zetasizer Nano ZS)
  • TGA-Thermogravimetric Analysis (TA Instruments)
  • DSC-Differential Scanning Calorimetry (TA Instruments)
  • Modulated DSC (TA Instruments)
  • ITC-Isothermal Calorimetry (Microcal)

 

Click Here To Download:
Brochure: Analytical And Microbiology Services
Brochure: Analytical Equipment List
Brochure: Metrics' Contract Pharmaceutical Development Laboratories Capabilities

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