Analytical Methods

Test methods and analytical technique references.

Analytical Methods

Analytical Method Validation — ICH Q2(R2) Parameters Overview

The validation parameters ICH Q2(R2) expects — accuracy, precision, specificity, and more — and how they connect.

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

Forced Degradation Studies — Design for Stability-Indicating Methods

How forced degradation studies are designed to challenge a method and confirm it is stability-indicating.

Analytical Methods

GC Method for Residual Solvents — ICH Q3C Compliant Approach

How gas chromatography methods are structured to test residual solvents against ICH Q3C limits.

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.

Analytical Methods

Mass Spectrometry in Impurity Identification — LC-MS Approach

How LC-MS is used to identify unknown impurities flagged by a related substances method.

Analytical Methods

Method Transfer — Protocol and Acceptance Criteria Between Labs

How an analytical method transfer protocol is designed to prove a receiving lab can run the method reliably.

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.