Development of Pfizer's Third Generation Turbidimetric Solubility Assay - An Engineering Perspective
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Development of Pfizer\'s Third Generation Turbidimetric Solubility Assay - An Engineering Perspective Presented at ISLAR 2002
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Development of Pfizer's Third Generation Turbidimetric Solubility Assay - An Engineering Perspective
- 1. Development of Pfizer's Third Generation Turbidimetric Solubility Assay - An Engineering Perspective Brian Bissett Molecular Properties Group Pfizer Global R&D Groton CT
- 7. History of Turbidimetric Assays at Pfizer G5143A
- 9. System Model of Turbidimetric Solubility Assay
- 12. Software Interface for Assay
- 13. Hach Controller Software GUI
- 21. Just how effective is this cleaning method ? When the Baseline “creeps” upward the wash cycles beat it back down preserving sensitivity.
- 22. Obstacle: Effective Mixing Within the Cuvette 1 2 3
- 25. Reflections can Imitate Legitimate Control Signals
- 29. Testing Performance of the New Assay: First a standard had to be created which would add a known quantity of Turbidity (NTUs) with each addition to the test solution (H 2 0) contained within the cuvette. Formula (from Hach Manual):
- 30. Testing Performance of the New Assay: Example: A single 1.0 µL addition of 1000NTU solution to a cuvette with a total volume of 2.5 mL.
- 32. Revising the Hach 2100N Turbidimeter Specs Revised Hach 2100N Turbidimeter Specifications: * The standard deviation of each successive addition was 0.001 NTUs. Original Hach 2100N Turbidimeter Specifications: 0.2 ±0.003* Repeatability .066 0.001 Resolution True NTU Value Displayed NTU Value Measurement N/A ±0.01 or 1.0% > of Repeatability N/A 0.001 Resolution True NTU Value Displayed NTU Value Measurement
- 33. Repeatability: 1000 NTU Testing CV’s 1.4% ~ 1.84%
- 35. Parallel Run (2483B Assay) “Ideal” Conditions
- 36. Parallel Run (2483B Assay) “Non-Ideal” Conditions Although 40% of the compounds had a different solubility, more often than not (75%) the difference was only 5 - 10 µg/µL.
- 37. Parallel Run (2483B Assay) “Non-Ideal” Conditions
- 38. Repeatability: Midrange Solubility Variation g/ L
- 39. “ Binning” the results – What do they mean? Retrain Your Chemists <15 >50 >15 <50 Potential Problems Drug Like Material