Application Note

Probing The Source Of An Unstable Impurity And Controlling Its Formation At Release

By Geraldine Su, Ken Strassberger, Craig Kramer, Xinqun Huang, Mike Markham, Adare Pharma Solutions

iStock-1169476198-team-solve-computer-desk

APT-76 is an anti-neoplastic agent and currently being developed as an extended-release formulation (enteric coating) for an ongoing early Phase 1 clinical trial. The finished drug product is a capsule filled with mini tablets. Two major issues related to impurities were encountered during the formulation and analytical stages.

Objectives

A critical step in an extended-release drug product analysis is the extraction during impurity and assay sample preparation. When both the drug substance and the impurity are unstable, this is especially challenging. This study is divided into three parts:

  1. Identification of the unstable impurity by LC/MS, and its mechanism of the formation.
  2. Probing the source of impurity formation during the extraction and manufacturing process.
  3. Improving the processing and extraction method to eliminate the formation of the impurity.
VIEW THE APPLICATION NOTE!

Get unlimited access to:

Trend and Thought Leadership Articles
Case Studies & White Papers
Extensive Product Database
Members-Only Premium Content
Welcome Back! Please Log In to Continue. X

Enter your credentials below to log in. Not yet a member of Outsourced Pharma? Subscribe today.

Subscribe to Outsourced Pharma X

Please enter your email address and create a password to access the full content, Or log in to your account to continue.

or

Subscribe to Outsourced Pharma