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FDCA Form 37 Approved21 CFR Part 11 Compliant
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Nitrosamine / NDSRI Testing

Detection of nitrosamine traces in APIs and drug products using LC-MSMS. Compliant with FDA/EMA requirements.

NitrosaminesNDSRILC-MSMSFDA/EMA
Detection LimitSub-ppm (0.01–0.1 ppm)
Turnaround Time10–15 working days
Regulatory AcceptanceUSFDA, EMA
Compounds Covered50+ nitrosamines
● Lab Capacity ActiveForm 37 Certified

Study Protocol Support

Direct access to analytical specialists for study design, method validation, and turnaround timelines.

Submit Sample MatrixDownload Service Spec Sheet
Direct Technical Desk:+91 76240 54108
Service Scope & Regulatory Framework

Rigorous Scientific Execution Built for Global Regulatory Dossiers

Jarvogen offers highly sensitive nitrosamine and NDSRI (Nitrosamine Drug Substance Related Impurities) testing using LC-MS/MS. Our validated methods detect nitrosamines at sub-ppm levels in APIs, drug products, and excipients. We support pharmaceutical companies in their nitrosamine risk assessment and control strategy as required by FDA and EMA.

Compendial Standards & Regulatory Alignment:
✓ FDA Nitrosamine Guidance✓ EMA Guidance✓ ICH M7✓ ICH Q3B
Dual-Analyst Review

100% 4-eye verification of all chromatograms, integrations, and calculations before CoA generation.

ALCOA+ Data Integrity

Direct electronic data capture with immutable audit trails, restricted rights, and disaster backups.

Technical SpecificationscGLP Compliant

Detection LimitSub-ppm (0.01–0.1 ppm)
Turnaround Time10–15 working days
Regulatory AcceptanceUSFDA, EMA
Compounds Covered50+ nitrosamines
Quality Credentials
FDCA Gujarat Form 37ICH Compliant (Q1–Q14)21 CFR Part 11
Key Analytical Capabilities

What's Covered in the Testing Scope

Comprehensive assay, stability, and characterization endpoints validated to global pharmacopoeial standards.

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NDMA, NDEA, NMBA, NIPEA, NDIPA detectionExecuted with validated SOPs and full raw data audit trails.
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NDSRI (drug-specific nitrosamines) analysisExecuted with validated SOPs and full raw data audit trails.
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Sub-ppm detection limitsExecuted with validated SOPs and full raw data audit trails.
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Nitrosamine risk assessment supportExecuted with validated SOPs and full raw data audit trails.
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Control strategy developmentExecuted with validated SOPs and full raw data audit trails.
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Confirmatory testing by multiple techniquesExecuted with validated SOPs and full raw data audit trails.
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Acceptable Intake (AI) limit comparisonExecuted with validated SOPs and full raw data audit trails.
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Regulatory submission supportExecuted with validated SOPs and full raw data audit trails.
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Batch release testingExecuted with validated SOPs and full raw data audit trails.
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Stability monitoring for nitrosaminesExecuted with validated SOPs and full raw data audit trails.
Qualified Laboratory Infrastructure

Validated Instrumentation & Data Systems

All instruments operate with full IQ/OQ/PQ qualification, automated audit trails, and 21 CFR Part 11 software packages.

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LCMS/MS (Triple Quadrupole)

Nitrosamine detection at sub-ppm levels

IQ/OQ/PQ QualifiedALCOA+ Audit Trail
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GC-MS/MS

Volatile nitrosamine analysis (NDMA, NDEA)

IQ/OQ/PQ QualifiedALCOA+ Audit Trail
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HPLC-UV

Screening and confirmation

IQ/OQ/PQ QualifiedALCOA+ Audit Trail
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Headspace GC-MS

Volatile nitrosamine screening

IQ/OQ/PQ QualifiedALCOA+ Audit Trail
Study Execution Lifecycle

How We Execute Your Study

Standardized 4-stage laboratory workflow ensuring traceability from sample intake to CoA release.

01
Stage 01

Risk Assessment

Nitrosamine risk assessment per FDA/EMA guidance; identification of potential nitrosamines.

02
Stage 02

Method Selection

Appropriate LC-MS/MS or GC-MS/MS method selected based on nitrosamine type.

03
Stage 03

Sensitive Analysis

Analysis at sub-ppm levels with certified reference standards and internal standards.

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Stage 04

AI Comparison & Report

Results compared against Acceptable Intake limits; regulatory-ready report issued.

Scientific Questions & Answers

Technical FAQs

Standard testing is delivered in 10–15 working days. Expedited priority slots are available upon request with dedicated instrument reservations and expedited QC review.
Ready for Sample Testing?

Initiate Your Nitrosamine / NDSRI Testing Study

Submit your sample matrix or request a pre-study analytical protocol discussion with our senior scientists today.

Schedule Scientific Consultation
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