Q2: Analytical Validation

by Dr. Yashashwini Reddy | Oct 8, 2025

🧪 ICH Q2: Analytical Validation 🔹 Full Title: ICH Q2(R2) – Validation of Analytical Procedures 🔹 Objective: To provide guidance on the validation of analytical methods used to test drug substances and products — ensuring that the methods are accurate, reliable, and...

Extraneous Peaks in Chromatographic Analysis

by Dr. Yashashwini Reddy | Aug 10, 2025

Extraneous Peaks in Chromatographic Analysis In chromatographic techniques like HPLC and GC, extraneous peaks are unwanted peaks in the chromatogram that are not related to the analyte(s) of interest, mobile phase, or expected impurities. They can distort quantitative...

System Suitability in HPLC Analysis

by Dr. Yashashwini Reddy | Aug 9, 2025

System Suitability in HPLC Analysis What is System Suitability? System Suitability Testing (SST) is a set of analytical checks performed before and during analysis to ensure that the HPLC system and method are capable of producing accurate, precise, and reproducible...

Why is Analytical Method Validation Required?

by Dr. Yashashwini Reddy | Aug 8, 2025

Why Analytical Method Validation is Required? Analytical Method Validation is essential to ensure that a test method is reliable, reproducible, and suitable for its intended purpose.It is required because: Regulatory Compliance Required by ICH Q2(R1), USFDA, EMA, and...

Steps for Analytical Method Development

by Dr. Yashashwini Reddy | Aug 8, 2025

Here’s a clear breakdown of the Steps for Analytical Method Development in pharmaceuticals, following regulatory expectations like ICH Q2(R2): Steps for Analytical Method Development Define the Objective (Method Purpose) Understand what needs to be measured (API,...