Case Study

Quality By Design Approach To Analytical Method Optimization

Source: Catalent
Powder

Quality by Design (QbD) is well established in the pharmaceutical industry for manufacturing processes, including active pharmaceutical ingredients and drug products. The knowledge obtained during development can establish the design space and determine suitable process controls. The novelty of the multivariate approach over the more traditional one-factor-at-a-time (OFAT) type of study is the ability to evaluate both the individual factor effects and the factor-factor interactions that can also be significant.

These same QbD principles have been applied to the development of analytical methods. In this case study, a QbD approach was used to solve a high-performance liquid chromatography (HPLC) analytical method problem where impurity peaks had shifting retention times making identification and quantitation problematic. For one critical pair of impurity peaks, the variability was large enough that an unpredictable reversal of elution order occurred that appeared to be column lot specific (same column, different lot).

VIEW THE CASE STUDY!
Signing up provides unlimited access to:
Signing up provides unlimited access to:
  • Trend and Leadership Articles
  • Case Studies
  • Extensive Product Database
  • Premium Content
HELLO. PLEASE LOG IN. X

Not yet a member of Drug Discovery Online? Register today.

ACCOUNT SIGN UP X
Please fill in your account details
Login Information
I'm interested in newsletter subscriptions.
ACCOUNT SIGN UP

Subscriptions

Sign up for the newsletter that brings you the industry's latest news, technologies, trends and products.

You might also want to: