Скачать или смотреть QQQ vs HRMS: Which Mass Spec Wins for Impurity Quantitation? Emery Pharma’s Bridging Study Reveals

Bridging Study: QQQ vs HRMS for Impurity Quantitation
📌 A Comparative Evaluation by Emery Pharma

Welcome to Emery Pharma’s latest study on bridging analytical methods for impurity quantitation! In this video, we’ll break down the comparison between Triple Quadrupole Mass Spectrometry (QQQ) and High-Resolution Mass Spectrometry (HRMS) for detecting and quantifying Impurity X in a drug product.

Scope of Work
The study aims to:
✔ Compare QQQ and HRMS in quantitation performance
✔ Assess regulatory compliance with FDA guidelines
✔ Determine the feasibility of method transfer between the two platforms

Key Findings
🔬 Selectivity & Specificity

Both QQQ and HRMS were tested for interference by comparing blank samples to Impurity X’s retention time.
Results: No interference was detected in either method.
📈 Linearity & Range

Known amounts of Impurity X were spiked into solvent, and instrument responses were plotted.
Both QQQ and HRMS showed strong linearity (R² greater than 0.9), proving their reliability across a range of concentrations.
✅ Accuracy

The accuracy was tested by preparing samples with known impurity levels and measuring them against nominal values.
Both QQQ and HRMS were within acceptable accuracy limits, ensuring valid quantitation.
🧪 In-Matrix Accuracy (Recovery)

The drug product was spiked with Impurity X to test measurement accuracy within a real matrix.
Both methods performed well, maintaining accuracy in complex sample conditions.
Conclusion: QQQ vs HRMS – Which One Wins?
QQQ: Excellent linearity, accuracy, and in-matrix performance.
HRMS: Comparable to QQQ with equally strong performance.
Final Verdict: Both techniques provide reliable quantitation of Impurity X and support method transfer within FDA-compliant parameters.
📢 What This Means for the Industry
This study confirms that both QQQ and HRMS are viable solutions for impurity quantitation, offering flexibility for regulatory submissions, method transfer, and impurity monitoring.

📌 Want to Learn More?
For full details on this study or inquiries about custom analytical services, contact Emery Pharma at [email protected] or visit our website.

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About Emery Pharma:
Emery Pharma is deeply committed to advancing public health and exclusively focuses on projects that enhance the well-being of both individuals and the environment. As a comprehensive contract research laboratory, Emery Pharma provides extensive support across the entire spectrum of pharmaceutical development, covering small molecule drugs, biologics, biosimilars, gene therapy, botanicals, and more.

Emery Pharma's array of premium services includes analytical and bioanalytical solutions, microbiology and cell biology services, drug and impurity characterization, and comprehensive R&D with cGMP/GLP support. The Emery Pharma team excels in customizing innovative solutions tailored to the unique requirements of each client. They seamlessly oversee the entire process, from initial drug discovery to thorough data analysis and insights generation. Their expertise allows them to tackle scientific challenges proactively, ensuring clients avoid unnecessary setbacks.

Emery Pharma's accomplished chemists and biologists harness state-of-the-art technology, encompassing cutting-edge tools such as high-resolution mass spectrometry (Orbitrap), triple quad LC-MS/MS, GC-MS, preparative HPLC, and 400 MHz multinuclear NMR.

For further details, please don't hesitate to reach out to Emery Pharma at [email protected] or explore their website at:
https://emerypharma.com/