Impurity Profiling
Chromatogen Analytical Laboratory offers end-to-end impurity profiling services to identify, isolate, quantify, and characterize trace impurities in active pharmaceutical ingredients (APIs), key starting materials (KSMs), and finished drug products. Operating in strict alignment with ICH guidelines (Q3A, Q3B, Q3C, and M7), USP, IP, EP, BP, and JP standards, our facility in Mysuru ensures your chemical materials meet global safety and compliance benchmarks.
Comprehensive Impurity Classification & Analysis
Impurity profiling is essential for establishing drug safety, defining shelf life, and ensuring smooth regulatory filings. We offer targeted analytical workflows across all major classes of impurities:
1. Organic Impurities (Process & Degradation-Related)
Process-Related Impurities: Identification of unreacted starting materials, by-products, intermediates, synthetic reagents, and side-reaction products.
Degradation Products: Tracking and profiling of degradation pathways formed during storage under thermal, hydrolytic, photolytic, and oxidative conditions (forced degradation / stress testing).
Isomers & Structural Relatives: High-resolution separation and quantification of regioisomers, stereoisomers, and closely related substances.
2. Trace & Mutagenic Impurities (ICH M7)
Nitrosamine Analysis: Ultra-sensitive detection and trace quantification of $N$-nitrosamines (NDMA, NDEA, NDIPA, etc.) down to sub-ppm levels.
Genotoxic / Reactive Impurities (GTIs): Targeted screening and method validation for alkyl halides, sulfonate esters, epoxides, and other reactive alkylating agents.
3. Residual Solvents & Volatile Organics (ICH Q3C)
Class 1, Class 2, and Class 3 Solvents: Headspace GC-FID/MS screening and quantitative evaluation to ensure residual solvents fall strictly within permitted daily exposure (PDE) limits.
Integrated Analytical Infrastructure
We combine high-resolution chromatography with advanced spectroscopic detection to achieve complete structural clarity for unknown trace impurities (even below the $0.1\%$ reporting threshold):
High-Resolution Mass Spectrometry (HRMS): Sub-ppm accurate mass measurement and tandem MS ($\text{MS}^n$) fragmentation for precise empirical formula assignment.
Nuclear Magnetic Resonance (NMR) Spectroscopy: High-field $^1\text{H}$, $^{13}\text{C}$, and 2D NMR (COSY, HSQC, HMBC) for absolute structural elucidation.
Liquid & Gas Chromatography: LC-MS/MS, HPLC-DAD/ELSD, and GC-MS setups for accurate chromatographic separation, isolation, and quantification.
Preparative Chromatography: Semi-preparative LC isolation of unknown impurities directly from bulk batches for subsequent structural confirmation or custom synthesis.
Industry Applications & Deliverables
Our impurity profiling capabilities support pharmaceutical manufacturers and R&D organizations through every phase of development:
Regulatory Submissions (DMF & ANDA): Complete impurity characterization data packages required for regulatory filing and tech transfer.
Quality Control & Batch Release: Routine impurity monitoring to ensure consistency and safety across production batches.
Stability Testing Support: Monitoring real-time and accelerated stability samples to detect and identify emerging degradants.
Uncompromised Precision. Complete Regulatory Safety.
At Chromatogen, we provide clear, actionable analytical data to identify and control impurities at every stage of product development. Our state-of-the-art laboratory combines rapid turnaround times with strict quality control to protect your product integrity.