Phase 4 – Purity Assessment & Analytical Validation
Phase 4 – Purity Assessment & Analytical Validation contains 8 topic pages in Pharmaceutical Chemistry.
Learning Objectives
- Describe the principal chromatographic and physicochemical methods used to assess compound purity.
- Explain the significance of chiral purity assessment for enantiomerically active drug candidates.
- Describe Karl Fischer titration and residual solvent analysis as complementary purity assessments.
- Explain each ICH Q2(R2) validation parameter and its role in establishing analytical method reliability.
- Interpret system suitability testing as an ongoing control on analytical method performance.
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Topics and Topic Groups
Browse the available learning units in this chapter.
HPLC Purity
High-performance liquid chromatography purity assessment quantifies the proportion of a sample's total detected chromatographic response attributable to the...
TLC Purity
Thin-layer chromatography purity assessment provides a rapid, low-cost, qualitative-to-semiquantitative purity check, in which a single, clean spot at the...
Chiral Purity
Chiral purity assessment quantifies the enantiomeric composition of a compound bearing one or more stereocentres, expressed as enantiomeric excess (the...
Elemental Analysis
Elemental analysis determines the percentage composition of carbon, hydrogen, nitrogen, and, where relevant, sulphur or halogen content within a compound...
Karl Fischer Titration
Karl Fischer titration provides highly precise, specific quantification of water content within a sample, exploiting a stoichiometric chemical reaction...
Residual Solvents
Residual solvent testing quantifies the level of organic solvents retained within a drug substance following synthesis and purification, and must...
Melting Point
Melting point determination remains one of the simplest and most rapid purity indicators available for a crystalline solid compound, exploiting the...
ICH Q2(R2) Analytical Method Validation
Introduction and Regulatory Purpose ICH Q2(R2), the internationally harmonised guideline on the validation of analytical procedures, establishes the formal...