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LC Method Validation™ - Automated Method Validation Software
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Works with Waters® and Agilent LC Systems controlled by:
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- Waters Empower™ (1 and 2) Chromatography Data Software (CDS)
- Agilent Chemstation® and Galaxie® CDS
- Dionex® Chromeleon® Chromatography Data Software (CDS)
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PhRMA’s Analytical Technical Group recommends a phased approach to analytical method validation in which early phase validation efforts are done upstream on a reduced set of validation elements appropriate to the stage of development.
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Early Phase Method Validation (Characterization)
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Fusion Method Validation™ (FMV) offers Early Phase experiments structured for internal consumption to support and guide method development.
- Analytical Capability and System Suitability
- Specificity
- Filter Validation
- Accuracy
- Linearity and Range
- LOQ, LOD
- Repeatability* (intra-assay precision)
- Sample Solution Stability (stability for a given time period under prescribed conditions)
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Final Phase Method Validation (FDA and ICH Submittal Quality)
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FMV offers Final Phase experiments structured with the rigor and regulatory compliance overlay required of results that may be exported outside the lab.
- Analytical Capability and System Suitability
- Specificity
- Accuracy/Linearity and Range/Repeatability – Combined Design (ICH-Q2A states that Accuracy, Linearity, and Repeatability can be done together as a single combined experiment)
- LOQ, LOD
- Intermediate Precision and Reproducibility (USP Ruggedness)
- Robustness
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Pharma Customer Benchmarking
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To benchmark time savings using FMV versus current practice, a senior analytical chemist at an international pharmaceutical account used FMV to complete a series of Early Phase and Final Phase method validation experiments. The entire method validation exercise took less than 12 hours using Fusion AE.
Work records showed that on average - from SOP planning and experiment design construction to final reporting - using “current practice” this project would have required more than two weeks of analyst time.
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For more information on Fusion LC Method Validation, contact us at 707-441-0404 or sales@smatrix.com
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