Nitrosamine & NDSRI Testing Capabilities – CA Analytical Testing Services

CA Analytical Testing Services provides comprehensive support for the identification, quantification, and control of nitrosamines and Nitrosamine Drug Substance-Related Impurities (NDSRIs). Our laboratory leverages advanced LC‑MS/MS, HRMS, and GC‑MS technologies to meet evolving global health authority expectations (FDA, EMA, Health Canada, ICH M7). We support pharmaceutical manufacturers from early risk assessments through full regulatory submission.

Core Capabilities

Ultra‑sensitive quantification of nitrosamines (low-ng/g or ng/mL detection).
Comprehensive nitrosamine panel: NDMA, NDEA, NMBA, NDBA, NEIPA, NDIPA, NPYR, NPIP, and emerging species.
NDSRI identification, characterization, and quantification using LC‑MS/MS and high-resolution MS.
Custom method development for drug-specific NDSRIs based on API structure and synthetic route.
GC‑MS analysis for volatile nitrosamines and complex matrices.
Root‑cause investigation support: nitrosation pathways, precursor assessment, and formation studies.
Extractables & leachables (E&L) testing to identify nitrosamine‑forming precursors from packaging.

NDSRI Testing Capabilities

Structural risk assessment to predict potential NDSRI formation based on API functional groups.
LC‑HRMS workflows for detection of unknown or unexpected NDSRIs.
Targeted quantification of known or predicted NDSRIs using vendor‑qualified reference standards or in‑house surrogates.
Forced nitrosation studies to identify realistic worst‑case impurities.
Support for establishing Acceptable Intake (AI) limits through structure‑activity evaluation aligned with ICH M7.

Ready to test with CA?

Reach out to one of our team members today for a quote or consultation!