Purpose and Importance

Nitrosamines and Nitrosamine Drug Substance-Related Impurities (NDSRIs) have emerged as a critical safety concern for the pharmaceutical industry. These impurities can form during manufacturing, storage, or formulation processes and are known to be potentially carcinogenic even at trace levels.

Global regulatory bodies such as the USFDA, EMA, MHRA, and CDSCO have established stringent acceptable limits for nitrosamine impurities and require validated analytical methods for detection and control. Monitoring and mitigating nitrosamines is essential to safeguard patient health and maintain regulatory compliance.

Routine nitrosamine testing helps pharmaceutical manufacturers ensure:

• Compliance with international safety regulations.
• Protection of patients from carcinogenic exposure.
• Early identification and control of manufacturing risks.

Our Testing Capabilities

At Accuprec Research Labs Pvt. Ltd., we employ state-of-the-art analytical instruments and validated methodologies to detect, identify, and quantify nitrosamines and NDSRIs with exceptional sensitivity and precision.

• Detection & Quantification: Using LC-MS/MS and GC-MS/MS platforms for accurate trace-level measurement (in ppb range).
• Method Development & Validation: Customized analytical protocols developed in line with ICH Q2(R1) guidelines.
• Risk Assessment: Evaluation of potential nitrosamine formation pathways during synthesis and formulation.
• Matrix Screening: Comprehensive testing of raw materials, intermediates, APIs, and finished products.
• Regulatory Support: Complete validation reports aligned with FDA, EMA, and CDSCO submission requirements.

Why Choose Accuprec

• GLP-Compliant Laboratory: Ensures data reliability and regulatory acceptance worldwide.
• High-Sensitivity Equipment: Capable of detecting impurities at ultra-trace (nanogram) levels.
• Experienced Analysts: Skilled professionals specializing in mass spectrometry-based impurity profiling.
• End-to-End Solutions: From analytical method development to regulatory documentation.

Outcome

Our Nitrosamine & NDSRI Testing services help pharmaceutical companies ensure their products meet the highest global quality and safety standards. By partnering with Accuprec, clients gain the confidence to navigate evolving regulatory expectations, mitigate risk, and safeguard patient health through robust impurity profiling and testing.