Elemental &
Nitrosamine Impurities
High-sensitivity trace analysis and risk assessment for pharmaceutical impurities, strictly adhering to ICH Q3D and the latest global regulatory mandates.
Navigating Trace Complexity
Even at sub-parts-per-billion levels, impurities can significantly impact patient safety and market viability. At BrownBiology Laboratory, we specialize in the detection and quantification of these elusive molecular threats.
Our GMP-certified laboratories are equipped with an array of high-precision mass spectrometry platforms, allowing us to execute comprehensive risk-based screening programs. We provide the definitive analytical evidence required to prove your product's purity and safety profile.
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Impurity Profiling Core
Defending the pinnacle of pharmaceutical purity through high-resolution detection.
Elemental Impurities (ICH Q3D)
Comprehensive screening and quantification of all Class 1, 2A, 2B, and 3 metallic elements using state-of-the-art ICP-MS platforms, ensuring absolute compliance with global pharmacopoeial standards.
Nitrosamines Analysis
Ultra-trace quantification of potential mutagenic impurities (NDMA, NDEA, NDIPA, etc.) using high-resolution GC-MS/MS and LC-MS/MS modules with extremely low Limits of Quantitation (LoQs).
Residual Solvents (ICH Q3C)
Vetting of pharmaceutical materials for Class 1, 2, and 3 residual solvents through HS-GC-FID/MS, ensuring systemic safety and solvent removal verification.
Organic Impurities (ICH Q3A/B)
Detailed impurity profiling of drug substances and products, identifying and quantifying degradation pathways and synthesis-related substructures.
Comprehensive Regulatory Support
Our impurity analysis programs are designed to satisfy the most demanding global health authorities. We provide full support for IND/NDA submissions, including detailed method validation reports, risk assessment documentation, and toxicological evaluation thresholds (AET).