When “It Works” Isn’t Enough
Your extractables and leachables screening method has been running reliably for years. It meets acceptance criteria. Delivers quality data. Gets the job done.
But legacy methods often remain frozen in time – validated once, then left unchanged even as better alternatives emerge. As pharmaceutical and healthcare industries increasingly prioritize sustainability alongside quality, a new question arises: can we make our methods work better while reducing their environmental footprint?
For many analytical laboratories, the answer is yes. But it requires asking the question.
Watch: Transforming E&L Screening Through Green Chemistry
In this video, Resolian senior scientist Joel Haines shares how the analytical sciences team redeveloped a routine high-resolution LC-MS screening method by implementing green chemistry principles – achieving better efficiency and sustainability without compromising analytical performance.
Extractables and leachables profiling is critical for pharmaceutical and healthcare applications, ensuring that substances migrating from packaging, delivery devices, or manufacturing equipment don’t compromise product safety or efficacy. These analyses require sensitive, reliable methods that detect and profile potential impurities across diverse matrices.
Joel’s work demonstrates that even well-established methods can evolve to become both more sustainable and more efficient.
What You’ll Learn in This Video:
- The opportunity presented when redeveloping a legacy LC-HRMS screening method
- Why ethanol was selected over acetonitrile as organic mobile phase
- Sustainability advantages of ethanol: lower production impact, reduced emissions and pollution
- Method optimization that reduced runtime from 30 to 19 minutes (37% reduction)
- Impact on solvent use, running costs, and laboratory throughput
- Validation results: meeting all acceptance criteria with no sensitivity loss
- Client perspectives on high-quality data with reduced environmental impact
The transformation wasn’t just about swapping solvents – it was about reimagining what the method could achieve while reducing its environmental burden.
The Green Chemistry Advantage
Switching from acetonitrile to ethanol as the organic mobile phase delivers measurable sustainability benefits:
- Lower production impact – Ethanol manufacturing generates significantly less pollution and fewer emissions compared to acetonitrile synthesis
- Renewable sourcing potential – Ethanol can be produced from renewable feedstocks
- Reduced hazardous waste – Lower environmental impact throughout the solvent lifecycle
- Cost considerations – Potential economic benefits alongside environmental gains
Combined with the 37% reduction in method runtime, these changes compound across hundreds or thousands of injections—translating to meaningful reductions in both environmental impact and operational costs.
Performance Without Compromise
The critical question for any method redevelopment: does it still work?
Joel’s redeveloped method met all previous acceptance criteria with no loss in sensitivity. This demonstrates that green chemistry implementations aren’t about sacrificing performance for sustainability—they’re about achieving both through smarter method design.
For pharmaceutical and healthcare clients, this means:
- Confidence in data quality and regulatory compliance
- Reduced environmental footprint for their analytical programs
- Potential cost savings through improved efficiency
- Alignment with corporate sustainability commitments
Rethinking Legacy Methods
Many analytical methods remain unchanged simply because they’re working. But “working” and “optimal” aren’t the same thing.
Whether you’re maintaining legacy methods or developing new ones, it’s worth considering:
- Can we reduce solvent consumption without compromising separation?
- Are there greener alternatives to current mobile phases?
- Can method optimization improve both efficiency and sustainability?
- Do current methods reflect best practices in green analytical chemistry?
These questions don’t just address environmental responsibility—they often reveal opportunities for improved efficiency, reduced costs, and increased throughput.
Expert E&L Analysis with Environmental Responsibility
Resolian’s analytical sciences team specializes in extractables and leachables profiling for pharmaceutical and healthcare applications, combining deep technical expertise with commitment to sustainable analytical practices.
Our approach integrates:
- Advanced LC-HRMS screening for comprehensive impurity profiling
- Green chemistry principles applied to method development
- Validation expertise ensuring regulatory compliance
- Global laboratory network supporting diverse project needs
Whether you’re seeking routine E&L testing or developing specialized methods for unique applications, we bring both the analytical capabilities and the environmental consciousness that modern pharmaceutical development requires.
Ready to discuss your extractables and leachables testing needs?
Contact our analytical sciences team to explore how we can deliver high-quality data with reduced environmental impact.
