How We Leverage HPLC and UHPLC Systems to Meet Your Regulatory Needs

In the highly regulated environments of pharmaceutical development and medical device testing, accuracy, reproducibility, and compliance are essential. Analytical testing is not just about generating data — it’s about generating trustworthy results that meet global standards. 

At CA Analytical Testing Services, our scientists specialize in High-Performance Liquid Chromatography (HPLC) and Ultra-Performance Liquid Chromatography (UHPLC) method development, providing clients with robust, validated methods that meet regulatory requirements and accelerate development timelines. 

HPLC and UHPLC: The Cornerstones of Analytical Quality 

High-Performance Liquid Chromatography (HPLC) 

HPLC is a proven analytical technique that separates and quantifies compounds in complex formulations. It plays a critical role in: 

• Assay and content uniformity testing 

• Impurity and degradation profiling 

• Dissolution and stability studies 

• Raw material verification 

• Extractables and leachables in medical device materials 

Ultra-Performance Liquid Chromatography (UHPLC) 

UHPLC represents a next-generation advancement, utilizing smaller particle sizes (<2 μm) and higher-pressure limits to achieve: 

• Superior resolution and sensitivity 

• Up to 70% faster run times 

• Lower solvent usage and greener workflows 

• Enhanced detection of trace impurities 

Together, these technologies form the foundation of modern analytical testing in pharmaceuticals and medical devices. 

Our Method Development Capabilities 

At CA Analytical Testing Services, we apply a structured, science-based, and regulatory-aligned approach to method development, optimization, and validation for both HPLC and UHPLC systems. 

1. Comprehensive Pre-Development Assessment 

Each project begins with an in-depth understanding of the sample: 

• Analyte solubility and stability 

• Chemical structure and UV/Vis profile 

• Potential degradation pathways 

• Matrix and excipient considerations 

2. Column and Mobile Phase Optimization 

We systematically screen: 

• Column chemistries (C18, phenyl, cyano, HILIC) 

• Buffer systems and pH ranges 

• Organic modifiers and gradient designs 

• Flow rate, temperature, and detection settings 

For medical device testing, we tailor our approach for polymeric materials, ensuring accurate quantification of extractables and leachables. 

3. Statistical Optimization and Robustness 

Using Design of Experiments (DoE) and advanced data modeling, we fine-tune parameters to: 

• Maximize resolution 

• Minimize analysis time 

• Enhance robustness and reproducibility 

4. Validation and Regulatory Alignment 

All developed methods undergo rigorous validation as per ICH Q2(R2), ICH Q14, USP <621>, ISO 10993, and FDA guidance. Key validation parameters include: 

• Specificity and accuracy 

• Precision and linearity 

• LOD/LOQ 

• Range and robustness 

Upon completion, we provide full method transfer and training support to ensure seamless adoption at client sites. 

UHPLC vs. HPLC: Selecting the Optimal Platform 

Parameter	HPLC	UHPLC
Particle Size	3–5 μm	<2 μm
Resolution	Excellent	Superior
Run Time	Moderate	Up to 70% faster
Sensitivity	High	Very high
Best Suited For	Routine QC, stability, and release testing	Rapid development, impurity profiling, and high-throughput screening

In many cases, an existing HPLC method can be successfully migrated to UHPLC, providing faster, more cost-effective results without sacrificing data integrity. 

Applications Across the Product Lifecycle 

Pharmaceutical Testing 

• API and finished product analysis 

• Stability-indicating method development 

• Cleaning validation studies 

• Dissolution and release testing 

Medical Device Testing 

• Extractables and leachables characterization 

• Residual solvent and monomer analysis 

• Material compatibility and biocompatibility support 

• Process validation and release testing 

Why Choose CA Analytical Testing Services? 

• State-of-the-art instrumentation — Advanced HPLC and UHPLC systems with DAD, CAD, fluorescence, and MS detectors 

• Regulatory expertise — Compliance with ICH, USP, EP, ISO, and FDA guidelines 

• Custom analytical solutions — Tailored to pharmaceutical formulations, combination products, and Class I–III medical devices 

• Efficient turnaround — High-throughput workflows designed to meet development and submission timelines 

Conclusion 

Accurate chromatographic methods form the foundation of quality assurance in pharmaceuticals and medical devices. Through expert method development in HPLC and UHPLC, CA Analytical Testing Services delivers reliable, compliant, and efficient analytical solutions that support your products from concept to commercialization. 

Partner with us to bring precision, compliance, and confidence to every chromatographic analysis. Click here to learn about our Method Development capabilities in more detail.