Services

Analytical Development

Averica Discovery Services, Inc.

Averica Offers HPLC Method Development & Validation Services

Our scientists develop analytical methods that are robust, transferable, reproducible, and designed to generate quality results.  Averica’s method development services ensure that your team makes the best decisions and hits drug development milestones.

METHOD DEVELOPMENT SERVICES

  • Purity, potency (assay), and quantify impurities
  • Stability indicating methods
  • Chiral purity and chiral release testing
  • ICH Q11 support, e.g. for qualification of regulated starting materials (RSMs)
  • Molecules with unique complexity or physical properties
  • Robust methods for fast method transfer

OUR APPROACH

Our goal is to fully understand both the requirements of the method and the nature of the compound.  Starting from this definition, we evaluate parameters and identify critical quality attributes.  This results in methods that are fit for purpose, ranged properly, and that can be quickly validated.

PROGRAM SPECIFIC METHOD DEVELOPMENT

Averica’s depth of experience with analytical method development and method qualification makes us uniquely suited to tough compounds and projects.  We’ve developed chiral methods for synthetic natural products with multiple stereocenters; solubility and buffer assays for amphoteric and multi-functional drugs, and reversed phase chiral methods for bioanalysis.  If the pharmaceutical compounds in your drug development programs don’t fit the simple models, talk to us.

 


Method Development Attribute

Averica evaluates and carefully considers each of the performance parameters and critical quality attributes (CQA) when developing a method.

  • System Suitability
  • Evaluation of Limit of Detection (LOD) & Limit of Quantitation (LOQ)
  • Linearity
  • Accuracy
  • Sample Stability
  • Standard Stability
  • Evaluation of Range
  • Mass Balance


Physical Properties Assay Panel

Averica helps late stage lead development teams understand the physiochemical properties of their lead compound.  The panel includes 5 components, resulting in a matrix of over 150 experiments.  This provides you with the most soluble and stable environment for your compound.

  • pH/solubility Profiling
  • Solubility Excipient Screening
  • Stability Indicating Method
  • Overall Stability
  • Forced Degradation
  • PSA – Indirect Measurement Through EPSA

Instrument & Detection Systems
  • SFC – Preparative & Analytical
  • HPLC – Preparative & Analytical
  • RP LC – Preparative & Analytical
  • UPC2
  • UPLC
  • GC
  • ELSD
  • MS
  • CAD Detection
  • PDA/UV
  • NMR
  • Accurate Mass MS
  • Click for more information about how we use our technology systems.

     

    The Averica Advantage

    • Emphasis on making sure that a chromatographic method meets your needs, and serves you development effort
    • Depth of experience with method development makes us uniquely suited to tough compounds and projects
    • Custom assay design and physical properties testing
    • Small scale assay development for when material is limited