How Preparative Liquid Chromatography Ensures Cleaner, Safer Pharmaceuticals
In pharmaceutical development, the isolation and identification of impurities are vital to ensuring the efficacy and safety of drug substances. Even in trace amounts, impurities can affect therapeutic outcomes or pose health risks. Preparative Liquid Chromatography (Prep-LC) has become an indispensable technique for isolating these impurities, enabling cleaner, safer formulations.
The Role of Prep-LC in Impurity Isolation
Unlike analytical HPLC, which focuses on detecting and quantifying compounds, Prep-LC allows the collection of impurities in sufficient quantities for further analysis and use. It is a scalable method designed to purify specific components from complex mixtures.
Prep-LC supports:
- Regulatory Compliance: Addresses impurity limits defined by global authorities such as the FDA and EMA.
- Safety Assurance: Facilitates detecting and removing toxic or unknown degradation products.
- Reference Standard Development: Enables the creation of qualified impurity standards for consistent quality control.
Our Approach to Prep-LC Services
Backed by modern instrumentation and skilled scientists, we provide end-to-end impurity isolation services using Prep-LC. Our process includes:
- Analytical Method Development
We first develop precise analytical HPLC methods to identify and quantify impurities accurately. These methods guide the preparative process.
- Scale-Up and Optimization
The validated method is then scaled up using larger columns and optimized solvent systems to isolate impurities effectively without compromising resolution.
- Fraction Collection and Monitoring
Targeted fractions are collected using UV/PDA detectors, ensuring the right components are precisely isolated and tracked.
- Purity Reconfirmation
Each collected impurity is re-evaluated using analytical HPLC to ensure purity levels typically above 90%, ensuring suitability for further us.
- Structural Elucidation
We utilize techniques like NMR, LC-MS/MS, FTIR, and UV spectroscopy to confirm the chemical structure of each isolated impurity.
Broader Analytical Capabilities
In addition to impurity profiling, our services include:
- Method Validation and Transfer: Ensuring methods are robust, reproducible, and compliant with .regulatory standards
- Stability Studies: Evaluating the behaviour of drug substances under varied environmental conditions.
- Regulatory Documentation Support: Providing technical data for submissions like ANDA or DMF.
We operate under ISO/IEC 17025:2017 (NABL) and ISO 9001:2015 certifications, reflecting our adherence to international quality standards.
Conclusion
Preparative Liquid Chromatography plays a central role in isolating impurities critical to drug safety and regulatory approval. With extensive experience and advanced infrastructure, we support global pharmaceutical companies in achieving superior quality benchmarks through reliable impurity profiling and characterization.
