Nitrosamine & Genotoxic Testing Overview

Nitrosamine & Genotoxic Testing Overview

Precision testing for safer pharmaceutical products.

Sciom provides GMP-compliant LC-MS and GC-MS testing for the detection and quantification of nitrosamine and genotoxic impurities across pharmaceutical dosage forms. Testing is performed in our MHRA-approved UK laboratory, delivering accurate, traceable, and audit-ready results to support regulatory compliance and impurity control.

LC-MS/GC-MS Testing Capabilities

Advanced technology. Reliable results.

Nitrosamine & Genotoxic Impurity Testing (LC-MS/GC-MS)
  • Targeted quantification of nitrosamines, NDSRIs, and genotoxic impurities (GTIs) classified under ICH M7 and TTC requirements.
  • High-sensitivity LC-MS/MS and GC-MS methods capable of detecting impurities at low parts-per-billion (ppb) levels.
  • Testing aligned with current EMA, FDA, and MHRA guidance for nitrosamine confirmatory analysis.
  • Validated methods for oral solids, liquids, sterile injectables, APIs, intermediates, and starting materials.
  • Positive and negative ion ESI and APCI with MRM acquisition for enhanced selectivity and sensitivity.
  • MS/MS fragmentation pattern confirmation to minimise false positives and improve identification accuracy.
  • Applicable to both drug substances (DS) and drug products (DP) across development, stability studies, and routine batch release testing.
  • Compliant with Ph. Eur., BP, USP, and ICH Q3A/Q3B impurity reporting requirements.
Dosage Form Coverage
  • Oral Solids: Nitrosamine and GTI profiling for tablets, capsules, and granules.
  • Liquids & Oral Solutions: Direct injection and dilute-and-shoot testing approaches.
  • Injectables & Sterile Products: Specialised sample preparation for complex matrices.
  • APIs, Intermediates & Starting Materials: Early-stage impurity characterisation and limit testing.
  • Raw Materials & Excipients: Nitrosamine risk screening for supplier qualification and incoming QC.

Nitrosamine & Genotoxic Testing Workflow

Every step. Fully traceable.

1

Sample Receipt & Chain of Custody

Samples are logged, assigned unique IDs, and verified against approved specifications and test requests.

2

Method Confirmation & STP Issuance

The appropriate LC-MS/GC-MS method and Standard Testing Procedure (STP) are confirmed before testing begins.

3

Sample Preparation

Samples undergo matrix-specific extraction and clean-up to maximise analyte recovery and minimise interference.

4

LC-MS/GC-MS Analysis

Samples are analysed using validated LC-MS/MS or GC-MS methods following system suitability verification.

5

Data Review & OOS Investigation

Results are independently reviewed, with any OOS findings investigated in line with GMP and ICH requirements.

6

Certificate of Analysis & Reporting

A Certificate of Analysis (CoA) is issued, supported by complete analytical documentation.

7

Archiving & Audit Readiness

Records are securely maintained with full audit trails, ensuring inspection and audit readiness.

Aligned with Global Regulatory Standards

Global standards. Proven compliance.

Sciom performs LC-MS/GC-MS nitrosamine and genotoxic impurity testing in accordance with current global regulatory expectations, supporting compliant regulatory submissions, marketing authorisations, and QP batch release activities.

  • ICH M7(R2) Compliance: Methods aligned with ICH M7 requirements for mutagenic impurities, including verification of acceptable intake (AI) limits for each analyte.
  • EMA & FDA Nitrosamine Guidance: Testing performed in accordance with current EMA CHMP guidance and FDA nitrosamine action plans, including confirmatory testing protocols.
  • MHRA GMP Accreditation: All testing conducted within our MHRA GMP-licensed UK laboratory, ensuring full control of regulated activities without subcontracting.
  • Ph. Eur., BP & USP Alignment: Methods validated against current pharmacopoeial requirements, supporting both compendial and client-specific specifications.
  • ICH Q2(R1) Validation: Analytical methods validated for specificity, linearity, accuracy, precision, robustness, LOD, and LOQ.
  • 21 CFR Part 11 Compliance: Electronic records and audit trails maintained in accordance with FDA 21 CFR Part 11 requirements.
  • ALCOA+ Data Integrity: Data managed in line with ALCOA+ principles to ensure records remain accurate, attributable, complete, consistent, enduring, and available.
  • ICH Q3A & Q3B Requirements: Reporting, identification, and qualification thresholds applied in accordance with ICH Q3A/Q3B impurity guidelines.
Regulatory Alignment

Nitrosamine Testing Expertise

Trusted expertise in trace-level detection.

Instrumentation & Analytical Capability

  • Triple quadrupole LC-MS/MS (MRM mode) for trace-level quantification of nitrosamines and genotoxic impurities (GTIs).
  • Electrospray ionisation (ESI) and atmospheric pressure chemical ionisation (APCI) for enhanced analytical flexibility.
  • Dedicated low-level testing environment with background nitrosamine monitoring to minimise contamination risk.

Method Development & Validation

  • Bespoke method development for novel nitrosamines, structural analogues, and TTC-applicable impurities.
  • Matrix-specific optimisation for complex dosage forms, including suspensions, emulsions, and modified-release products.
  • ICH Q2(R1)-compliant validation covering specificity, linearity, accuracy, precision, LOD, and LOQ.
  • Method transfer and suitability assessments to support regulatory requirements and batch release activities.

Sample Preparation

  • Solid-phase extraction (SPE) for matrix clean-up and analyte enrichment.
  • Accelerated solvent extraction (ASE) for solid oral dosage forms.
  • Headspace techniques for volatile nitrosamines where applicable.

Data Management & Reporting

  • Pharma Plus LIMS integration for sample tracking, data capture, and STP management.
  • 21 CFR Part 11-compliant chromatography data systems (CDS) with full electronic audit trails.
  • Secure client portal with real-time batch status visibility and CoA access.
  • Results reported as ng/day, ppm, and percentage of acceptable intake (AI) limits.
  • Complete analytical packages prepared for regulatory submissions, including method and validation summaries.

Your Partner for Nitrosamine & GTI Testing

One laboratory. One team. Complete accountability.

Single Laboratory. Complete Accountability.

All LC-MS/GC-MS nitrosamine and genotoxic impurity testing is performed within our MHRA-approved UK laboratory, eliminating the risks and delays associated with subcontracting. Integrated support for nitrosamine testing, QC batch release, importation, and QP release simplifies regulatory oversight and supply chain management.

Expert Scientific Team

Our scientists bring specialist expertise in nitrosamine chemistry, regulatory toxicology, and mass spectrometry. Complex analytical challenges, atypical results, and regulatory queries are managed directly by experienced technical experts.

Real-Time Transparency

Every project is tracked through the Sciom client portal, from sample receipt and testing through to data review and CoA issuance. Real-time status updates support informed planning and faster decision-making.

Regulatory Alignment & Inspection Readiness

Testing is performed in line with current ICH M7, EMA, FDA, and MHRA expectations. Electronic records, barcoded workflows, and structured audit trails support ongoing inspection readiness.

Faster Turnaround Without Compromise

Our integrated eQMS and digital workflows streamline testing, reporting, and CoA issuance, helping accelerate QP batch release while maintaining data quality and compliance.

Our CDMO Service

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