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Spectral Databases
Research Library
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Advanced Chemistry Development (ACD/Labs)
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Quality by Design (QbD) was first described by Joseph M. Juran,[1] and applied with great success, particularly in the automotive industry. The underlying concept of QbD is that quality must be “designed in” to a product through the systematic implementation of a strategy to establish a complete understanding of the product and the processes used to develop and manufacture it. Control strategies ...
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Pace Analytical Life Sciences, LLC
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Method Advantages
Broad range of selectivity for detection of compounds (organic and inorganic)
Multiple spectral regions can be used to quantify compounds
Recent ASTM, NIOSH & EPA approvals
-Methods have been validated
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Pace Analytical Life Sciences, LLC
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Drivers for Alternative Methods
Meet new standard requirements for 10993-7 & 10993-18
Research alternative methodologies for Chemical Characterization
Determine compliant, cost effective “One Shot Analysis”
Seek method that minimizes product consumption
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Pace Analytical Life Sciences, LLC
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Preclinical Testing for the Medical Device Industry – Material Properties, Leachables/Extractables, and Surface Cleanliness
Jonas Weissenrieder, Ph.D. Pace Analytical Life Sciences Oakdale, Minnesota
Effects of Material and Chemical properties on the biological profile
Chemical and Material Analysis
Why do chemical characterization? Equivalence studies? Economy?
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Pace Analytical Life Sciences, LLC
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Quantitative analysis using high resolution gas phase considers shelf life, corrosion, degradable polymers, drug potency, package permeability, and sterilization optimization.
This guide analyzes the challenges facing and solutions on Headspace Moisture.
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