Reference Standard Management

EAG offers comprehensive reference standard management services—from initial characterization through distribution, including requalification, purification and custom synthesis.

Superior quality systems and unparalleled analytical expertise

Analytical reference standards fall into the category of things that are easy to forget—until the moment you learn you don’t have what you need to start a time-sensitive study. Put EAG Laboratories’ superior quality systems and analytical expertise to work for you. We know how to deliver the peace of mind that comes with a centralized, professionally managed reference standard program.

  • A validated, GXP-compliant LIMS system including barcoding, established storage and inventory tracking and reporting, shipping to external vendors, and an automated notification system for triggering retest and reorder
  • In-house custom synthesis and radiolabeling expertise to efficiently replenish all types of standards (primary API reference material, internal standards, degradants, metabolites, and impurities–including mutagenic/genotoxic impurity standards)
  • Secure DEA-licensed facility for controlled reference standard storage
  • Protocol-driven sub-aliquoting from primary container to lower contamination risk
  • Unparalleled characterization and identification expertise, and an arsenal of spectroscopy and other analytical techniques for primary reference standard characterization, reference standard purity and retest/requalification, and rapid generation of Certificates of Analysis (CoAs).

Single-source convenience for reference standard management

When you partner with EAG, you enjoy the single-source convenience of a truly analytically focused CRO. Our arsenal of instrumentation is both broad and deep—so whether your protocols require typical tools of the trade or less common techniques, we have you covered.

  • Reference Standard Characterization and Identification Techniques
    • Optical Rotation
    • FTIR
    • Mass Analysis-MS and MS/MS
    • XRD
    • NMR
      • 2-Dimensional NMR: COSY, NOESY, DOSY, HMQC, HMBC, TOCSY, HSQC
      • Q-NMR – Qauntitative NMR for purity assessment
  • Reference Standard Purity Assessment
    • HPLC Purity & Impurities
    • GC and GC/MS volatile impurities including Residual Solvents
    • Water Content by Karl Fischer (Karl Fischer-Coulometric, Oven, and Volumetric
    • Specific Rotation
    • Chiral Purity
    • UV/Vis
    • Residue on Ignition
    • Traditional Heavy Metals or Elemental Analysis via ICP-MS
    • Counter Ion Analysis

Download our white paper: The ABCs of Reference Standards Management by Harley Wilcox, Senior Scientific Advisor.  Need a quote for your reference standard testing or management program? Call us today at +1 800 538-5227.

 

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