Tagged "analytical-chemistry"

Analytical Method Validation — Robustness Testing Approach

How robustness testing evaluates whether small deliberate method changes affect results.

Analytical Methods

Dissolution Method Development — Discriminating Method Design

How to design a dissolution method sensitive enough to detect meaningful formulation or process changes.

Analytical Methods

HPLC Method Development — Systematic Approach for Assay Methods

A step-by-step approach to developing a robust HPLC assay method from scouting to finalization.

Analytical Methods

Karl Fischer Titration — Water Content Determination Method

How volumetric and coulometric Karl Fischer titration methods determine water content in pharma materials.

Quality Control

Stability-Indicating Method — Development and Validation Requirements

What makes an analytical method genuinely stability-indicating, and how that is demonstrated.

Analytical Methods

System Suitability Testing — HPLC Requirements per USP <621>

The system suitability parameters USP <621> expects before an HPLC method result can be trusted.

Analytical Methods

UV-Vis Spectrophotometry — Method Validation for Assay Testing

What validation looks like for a UV-Vis spectrophotometric assay method.