Analytical Method Quality

Control of Quantitative Analytical Methods

Xceleron employs a range of quality control standards designed to characterize and control quantitative analytical LC + AMS methods.  These are designed to control as follows:

  • The dynamic range across which the entire analytical process is deemed in control
  • Accuracy of measurement across the dynamic range for the entire process
  • Precision of measurement across the dynamic range for the entire process
  • Accuracy and precision across the dynamic range for graphitization and detection steps
  • Carryover during transfer of carbon to the detector
  • Accuracy and precision across the dynamic range for the AMS detector

 

Quality-Control-Standards-at-each-step

 


Xceleron Quantitative Analytical Methodology Checklist

The transfer of a LC or LC-MS/MS assay for use by LC+AMS entails significant changes and  requires care followed by a full validation of the LC+AMS assay. Limited aspects of a previously validated LC or LC-MS/MS may be directly transferrable but insufficient testing of an LC+AMS method may introduce significant risk to the clinical study objectives and developmental timelines.

Xceleron routinely applies the following standards

Xceleron's Method Transfer Checklist

Xceleron's Three Batch Validation Checklist

Xceleron's Post Validation Checklist

Xceleron’s use of careful method transfer and three-batch validation has produced reproducible analytical methods that are accurate and precise.

Cal Std Accuracy

Cal Std Accuracy 2016

QC Accuracy

QC Accuracy 2016

QC Precision

QC Precision 2016

 


Download our guide to transferring and validating quantitative analytical methods for LC+AMS here

  • Latest News

    Pharmaron Acquires Majority Stake in SNBL CPC

    Read more »

  • What our clients are saying about us...

    "...AMS [is] an invaluable tool in our early drug development program, allowing us to quickly assess bioavailability in humans and focus resources on our most promising drug candidates going forward."

    See more client quotes »

  • Get Phase II Ready

    Find out how we can help you accelerate your drug-development program.

    Email us now »

© Xceleron 2017 All Rights Reserved.