#analytical method validation

Specificity This concept is essential in scientific analysis. When you create a method to measure something (like a drug or a chemical), you must prove that the method only measures that specific substance and isn’t being ‘fooled’ by other things in the mixture. ​Case 1: (Specificity / No Interference) Like a clear road, the signal you are looking for passes through without being blocked or…

​Goal of Validation: Analytical validation proves that a testing method works correctly for its intended use. ​Why it Matters: Accurate testing ensures that medicines are safe, effective, and of high quality. Because of this, regulators have required validation for many years. ​What is the ICH?: The International Conference on Harmonisation (ICH) started in 1990. It is a group where regulators…

FTIR METHOD DEVLOPMENT Fourier Transform Infrared Spectroscopy (FTIR) is widely used in analytical method development because it provides rapid, sensitive, and eco‑friendly characterization of pharmaceutical substances, excipients, and formulations. It is especially valuable for fingerprinting Active Pharmaceutical Ingredients (APIs) and validating methods without the need for solvents.  — …

What a Wedding Day Can Teach You About Perfect Lab Results1. Introduction: The Universal Language of AnalogyHave you ever felt locked out of a conversation by technical jargon? Science, in particular, can feel like an intimidating world of its own. But the truth is, even the most complex ideas can be unlocked with a simple key: a powerful, relatable story.The secret to understanding a critical…

1. EDQM / EU GMP (Europe) ​Focus: The European approach places heavy emphasis on the Qualified Person (QP). The QP acts as the gatekeeper and must personally ensure that any deviation does not violate the Marketing Authorization (MA). ​Risk Management: EU GMP explicitly ties deviation handling to ICH Q9 (Quality Risk Management). You must categorize deviations (e.g., Minor, Major, Critical)…

A sequence of 15 samples (ID: LIR-20251123-A) was being run for the quantitative analysis of [Specify Compound/Analyte] in [Specify Matrix, e.g., pharmaceutical tablet, environmental water sample]. The sequence included standards, blanks, and quality control (QC) samples.Point of Interruption: The interruption occurred during the analysis of the 7th sample (ID: LIR-20251123-A-07), approximately 3…

Understood. “Analytical image method validation” refers to the process of ensuring that image-based methods used for quantitative or qualitative analysis consistently produce reliable, accurate, and fit-for-purpose results. This is crucial in fields like pharmaceuticals, materials science, environmental monitoring, and medical diagnostics, where image data drives critical decisions.Here’s a…

This sounds like you’re looking for a Standard Operating Procedure (SOP) for Ultraviolet (UV) analysis. Here’s a general outline of what a comprehensive SOP for UV analysis would typically include. Keep in mind that the specific details will vary depending on the instrument model, the type of analysis being performed, and your laboratory’s quality system requirements.1. Objective: * Clearly state…