A fast, Powerful, and Cost-Effective Solution for the Determination of Heavy Metal Impurities using a Combination of High Resolution UPLC and Microwave Digestion

Library Number:
WEBC134851329
Author(s):
Antonio Ramos and Lúcia Volta e Sousa
Source:
Waters Corporation, Select Science, and Hovione
Content Type:
On Demand Webinar

Presented by:

  • Antonio Ramos, Analytical Development Group Leader, Hovione SC (Loures, Portugal)
  • Lúcia Volta e Sousa, PhD Student, Hovione

Hosted by: Select Science and Waters Corporation

Elemental impurities analysis has a great importance within the pharmaceutical realm due to their potential impact on quality, safety, and efficacy. These impurities can include catalysts and environmental contaminants that may be present in drug substances, excipients, or drug product. For that reason, it is necessary to implement a rigid control step during the manufacturing process in order to assure that the final product is within the specification limits described in USP chapter <232> and the recently approved ICH Q3D guideline. The two procedures acknowledged by the USP, which can be used to analyze and control these materials, are ICP-MS and ICP-AES. However, these techniques are expensive and are not usually available at manufacturing sites. According to USP <233> alternative procedures that meet validation requirements are acceptable.

During this webinar we discuss an alternative approach for the control of elemental impurities, using microwave/UPLC/UV-VIS. Microwave-based digestion provides a universal method that can be applied to any organic matrix. This is combined with the high performance and functionality of the ACQUITY UPLC System and methods are developed within a Quality by Design framework. This is a powerful, advantageous and fast solution for heavy metals determination with improvements over traditional methods in terms of time and cost savings.

Key Learning Objectives:

  • Elemental impurities: Why we need to control them throughout the chemical process?
  • Risk assessment for method development: What needs to be tested?
  • Design of experiments: qualitative factors vs quantitative factors
  • How to minimize time and costs associated with elemental impurity analysis

This webinar was hosted live by Select Science on July 15th, 2015. Watch on-demand