Advanced Nitrosamine
& NDSRI Testing
Services
Accurate Detection of Trace-Level Nitrosamine Impurities for Global Regulatory Compliance.
NDMA, NDEA, NEIPA, NDIPA, NDBA, NMBA & NDSRIs analysis using validated LC-MS/MS and GC-MS/MS methods aligned with USFDA, EMA, ICH M7, and global regulatory expectations.
Trusted Nitrosamine Testing CRO in India
Accuprec Research Labs Pvt. Ltd. is a globally accredited Contract Research Organization (CRO) providing comprehensive Nitrosamine and Nitrosamine Drug Substance Related Impurities (NDSRIs) testing services for pharmaceutical manufacturers worldwide. The laboratory operates from a state-of-the-art 120,000+ sq. ft. facility in Ahmedabad, India, serving clients across 60+ countries.
Our scientific team delivers highly sensitive analytical solutions for trace carcinogenic impurities in:
- APIs
- Drug products
- Excipients
- Packaging materials
- Stability samples
- Process intermediates
Why Nitrosamine Testing Matters?
Regulatory Focus on Carcinogenic Impurities
Nitrosamines are classified as probable human carcinogens and are tightly regulated by global health authorities including:
- USFDA
- EMA
- MHRA
- Health Canada
- WHO
- ICH
Pharmaceutical manufacturers are now required to perform:
- Nitrosamine risk assessments
- Confirmatory analytical testing
- Root cause investigations
- Continuous monitoring
- Regulatory submissions
Accuprec supports end-to-end compliance with validated, audit-ready analytical solutions.
Nitrosamines We Test
Our comprehensive testing panel covers all major nitrosamine impurities regulated by USFDA, EMA, and global health authorities.
| Nitrosamine | Full Form |
|---|---|
| NDMA | N-Nitrosodimethylamine |
| NDEA | N-Nitrosodiethylamine |
| NEIPA | N-Nitrosoethylisopropylamine |
| NDIPA | N-Nitrosodiisopropylamine |
| NDBA | N-Nitrosodibutylamine |
| NMBA | N-Nitroso-N-methyl-4-aminobutyric acid |
| NDSRIs | Nitrosamine Drug Substance Related Impurities |
Our Testing Capabilities
LC-MS/MS Based Nitrosamine Analysis
Highly sensitive quantification methods for volatile and non-volatile nitrosamines with ultra-low detection capability.
GC-MS/MS Analysis
Specialized analysis for volatile nitrosamines using USFDA-aligned methods.
HRMS Screening
Advanced untargeted screening for unknown or emerging nitrosamine impurities.
Method Development & Validation
Complete analytical method development and validation as per ICH Q2(R2), ICH M7, FDA Guidance and EMA Guidance.
Our Nitrosamine Testing Services
Nitrosamine Risk Assessment
Identify potential sources and formation pathways of nitrosamine impurities.
Confirmatory Testing
Sensitive quantitative analysis using validated analytical methods.
NDSRI Assessment
Custom analytical approaches for drug-substance-related nitrosamines.
Method Validation
Full validation including Specificity, Accuracy, Precision, Linearity, Robustness, LOD & LOQ.
Stability Studies
Nitrosamine monitoring under accelerated and long-term stability conditions.
Regulatory Submission Support
Complete technical documentation support for:
- ANDA
- DMF
- CTD/eCTD submissions
Supporting Global Pharmaceutical Manufacturers
We provide nitrosamine testing solutions for:
Pharmaceutical companies
API manufacturers
CDMOs
Generic drug manufacturers
Innovator companies
Medical device companies
Packaging manufacturers
Scientific Excellence. Regulatory Confidence.
Globally Accredited CRO
- ISO/IEC 17025:2017
- OECD-GLP
- USFDA
- EMA
- NABL
- AAALAC
- CDSCO
State-of-the-Art Infrastructure
- 120,000+ sq. ft. advanced laboratory facility
- Advanced LC-MS/MS & GC-MS/MS instrumentation
- Dedicated nitrosamine analytical capabilities
Experienced Scientific Team
Expert scientists with extensive experience in impurity profiling, analytical development, and regulatory compliance.
Global Regulatory Support
Supporting submissions across US, Europe, Canada, and regulated international markets.
Our Nitrosamine Testing Process
Sample Assessment
Understanding product composition and regulatory requirements.
Risk Evaluation
Identification of potential nitrosamine formation pathways.
Method Selection & Development
Customized analytical method optimization.
Sample Analysis
Sensitive testing using LC-MS/MS or GC-MS/MS platforms.
Data Review & Reporting
Comprehensive audit-ready reports with regulatory support.
Requirement Understanding
We begin by understanding your product, testing requirements, and regulatory objectives.
Method Development & Planning
Our team develops and optimizes analytical methods aligned with ICH, USP, and global standards.
Testing & Analysis
Samples are tested using advanced LC-MS/MS, GC-MS/MS, and HRMS instrumentation.
Reporting & Compliance Support
Detailed, audit-ready reports for ANDA, DMF, and CTD/eCTD regulatory submissions.
