Impurity Profiling

Ensuring Purity, Safety, and Compliance from the Start

At Amoli CDMO, we recognize that impurity profiling is fundamental to developing and manufacturing high-quality, compliant pharmaceutical products. Our analytical and process chemistry teams work hand-in-hand to identify, characterize, and control impurities at every stage of development — ensuring patient safety, product efficacy, and global regulatory compliance.

Impurity profiling at Amoli is not just a testing step — it’s an integral part of our Quality by Design (QbD) framework, enabling us to understand the chemical behavior of each process and design effective control strategies early in development.

Comprehensive Impurity Profiling Capabilities

Our analytical laboratories are equipped with advanced instrumentation and data-handling systems to perform qualitative and quantitative impurity assessment in accordance with ICH Q3A (R2) and Q3B (R2) guidelines.

Our key capabilities include:

• Identification and quantification of organic impurities, inorganic impurities, and residual solvents
• Characterization of process-related and degradation impurities
• Forced degradation and stress testing to establish degradation pathways and stability-indicating methods
• Profiling of chiral, isomeric, and genotoxic impurities
• Nitrosamine risk assessment and analytical detection methods
• Development of structure–activity relationship (SAR) insights to determine impurity impact on product quality and safety

Our teams use LC–MS/MS, GC–MS, ICP–MS, NMR, HPLC/UHPLC, and Fourier-transform infrared spectroscopy (FTIR) to ensure precise detection, identification, and quantitation — even at trace levels.

Process Understanding and Control

By integrating process chemistry with analytical science, we build a deep understanding of impurity formation mechanisms.

This enables Amoli to:

• Trace impurities back to specific raw materials, intermediates, or reaction steps
• Design targeted purification or control strategies
• Minimize impurity carry-over through optimization and process redesign
• Predict impurity profiles during scale-up and tech transfer

Such predictive control helps our partners mitigate risk early, ensuring that each manufacturing process is both robust and regulatory-ready.

Genotoxic and Nitrosamine Impurity Evaluation

Amoli conducts comprehensive genotoxic impurity (GTI) and nitrosamine risk assessments as part of its impurity profiling program.

Our experts apply structure-based hazard evaluation, threshold of toxicological concern (TTC) principles, and validated analytical methods to identify, quantify, and control potential genotoxic species.

By implementing these controls during the development and validation stages, we ensure that our products meet — and often exceed — international safety expectations.