Analytical method development in the quality by design framework

• The development of analytical methods in the Quality by Design (QbD) framework is currently gaining great momentum in the pharmaceutical industry. Presented here is a case study in which a pharmaceutical Quality Control (QC) method was developed using HPLC. The possibilities of continuous improvements during the method’s lifetime are demonstrated by switching to ultrahigh performance liquid chromatography (UHPLC).

Subject headings

TEKNIK OCH TEKNOLOGIER  -- Kemiteknik (hsv//swe)

ENGINEERING AND TECHNOLOGY  -- Chemical Engineering (hsv//eng)

Keyword

analytic method; Article; drug industry; high performance liquid chromatography; particle size; quality control; temperature; ultra performance liquid chromatography

Chemical Engineering

Kemiteknik

Publication and Content Type

ref (subject category)

art (subject category)