by maheshbhuva | Jan 26, 2026 | Analytical Chemistry, Analytical method development hplc,, Method validation, Quality control (QC)
1. Define the Purpose and Scope Establish the method’s objective before you begin writing. Method Title: Assign a descriptive name (e.g., “HPLC Method for the Quantification of Paracetamol in Tablets”). Objective: State exactly what the method...
by maheshbhuva | Jan 10, 2026 | Analytical Chemistry, Analytical method development hplc,, ICH Guideline, Method validation, Quality control (QC)
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,...
by maheshbhuva | Dec 4, 2025 | 21 CFR, Analytical Chemistry, Deviation, ICH Guideline, Quality control (QC)
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...
by maheshbhuva | Feb 19, 2025 | Hplc
1. What is HPLC? Answer:HPLC stands for High-Performance Liquid Chromatography. It is a technique used for separating, identifying, and quantifying components in a mixture. It uses a liquid mobile phase under high pressure to pass through a column containing a...
by maheshbhuva | Jul 28, 2023 | 621 USP CHAPTER, Analytical Chemistry, Hplc
What is update change Definitions Here Definitions and chromatograms both unified and give title Definitions Give method dwell volume determine being added Definitions add definitions size-exclusion chromatography  (Distribution constant, Retention time of an...