Ensuring Medicine Safety with Nitrosamine & NDSRI Testing

Introduction

In today’s pharmaceutical industry, ensuring patient safety is more critical than ever. Even trace levels of harmful impurities can impact drug safety, efficacy and regulatory compliance. Nitrosamines and NDSRIs are two such impurities that can form during drug manufacturing or storage and their presence—even in minute amounts—can pose serious health risks.

At Accuprec Research Labs, we specialize in Nitrosamine & NDSRI Testing, helping pharmaceutical companies detect and mitigate these risks before they reach patients.

What Are Nitrosamines & NDSRIs?

Nitrosamines and NDSRIs (Nitrosamine Drug Substance Related Impurities) are chemical impurities that may unintentionally form during manufacturing or storage. Even at trace levels, they can compromise patient safety and result in non-compliance with global regulatory standards. Detecting them early is key to safe drug development and maintaining trust in your brand.

Why Testing Matters

• Patient Safety: Prevent exposure to potentially carcinogenic compounds.
• Regulatory Compliance: Ensure adherence to FDA, EMA and CDSCO guidelines.
• Quality Assurance: Build and maintain confidence in your pharmaceutical products.

How Accuprec Ensures Compliance

Our testing approach combines advanced technology with expert analysis:

• High-Precision Instruments: LC-MS/MS & GC-MS/MS for accurate detection
• Validated Methods: Reliable, sensitive detection of trace impurities
• Comprehensive Reports: Data ready for regulatory submission

Our Testing Workflow Includes

1. Identification of Impurities – Detecting potential risks early
2. In-silico Toxicity Assessment – Predicting harmful effects
3. Analytical Method Development & Validation – Ensuring accuracy
4. Exposure Assessment – Understanding patient risk
5. Risk Assessment Report – Summarizing findings for decision-making
6. Toxicology Testing (In-vitro & In-vivo) – Confirming safety

Meet Us at CPHI Frankfurt 2025

We’re excited to showcase our expertise at CPHI 2025. Visit Stall D96 | Hall 6.1 at Messe Frankfurt, Germany to explore how Accuprec ensures medicine safety and regulatory confidence worldwide.