Related Substance Testing Explained | HPLC Method, Impurity Limits & Pharma QC MediDost

In this video, you’ll learn everything about Related Substance Testing, one of the most critical analytical tests performed in pharmaceutical quality control laboratories.

We will cover:

✅ What is Related Substance Testing?
✅ Why impurity testing is important for patient safety
✅ Types of impurities (Process, Degradation & Unknown Impurities)
✅ HPLC principle used in Related Substance Analysis
✅ System Suitability Requirements
✅ Reporting Threshold, Identification Threshold & Qualification Threshold
✅ ICH Guidelines (Q3A & Q3B) Overview
✅ Chromatogram Interpretation
✅ Difference Between Assay and Related Substance Testing
✅ Common Interview Questions for Pharma QC Professionals

Related Substance Testing helps ensure that medicines are not only potent but also free from harmful impurities that can affect safety, efficacy, and regulatory compliance.

Whether you’re a B.Pharm/M.Pharm student, a QC analyst, preparing for pharmaceutical interviews, or working in the pharma industry, this video will help you understand the concept from basics to practical application.

📌 Remember:
Assay tells us how much API is present, while Related Substance Testing tells us what else is present.

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