Applications of Reference Materials in Analytical Chemistry

By: Peter Roper, Vicki J Barwick, Shaun Burke, Ron Walker, Richard Lawn

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Hardcover | 1 December 2001

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Hardcover
160 Pages

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24.77 x 16.51 x 1.91

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I Reference materials play an important role in analytical chemistry, where they are used by analysts for a variety of purposes, including: checking and calibrating instruments; validating methods and estimating the uncertainty of analytical measurements; checking laboratory and analyst performance; and internal quality control. This book provides guidance and information for the users of certified reference materials (CRMs), explaining how they can best be used to achieve valid analytical measurements and improve quality in the analytical laboratory. General information on CRMs and how they are produced sets the scene for readers. The statistics relating to CRM use are then explained in an easy-to-understand manner, and this is followed by sections covering the main uses of CRMs. Detailed worked examples are used throughout. Structured and comprehensive in coverage, this book will be welcomed by all users of certified reference materials.

Industry Reviews

"This handbook could serve equally well at the desk or bench, both in providing information and promoting good laboratory practice...Clearly laid out and with liberal, well-labelled illustrations this is an up-to-date, comprehensible reference that I recommend highly." * Chemistry in Britain, February 2002, p 51 * "... a very useful and well presented contribution to the QA/QC literature ..." * The Analyst Website, 2001 *

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Non-Fiction Science Chemistry Analytical Chemistry Education Science in General Scientific Equipment

Introduction	p. 1
Certified Reference Materials and the VAM Principles	p. 1
Definitions and Hierarchy of Reference Materials	p. 2
Types of Reference Material	p. 4
Uses of Reference Materials in Analytical Chemistry	p. 5
Interpretation of Results Obtained with CRMs	p. 5
Availability of Reference Materials	p. 6
Quality of Certified Reference Materials	p. 6
References	p. 7
CRM Production	p. 8
Assessment of Priority Needs and Confirmation of Demand	p. 8
Literature Search and Project Plan	p. 8
Raw Material Selection and Processing	p. 9
Homogeneity Testing	p. 10
Stability Testing	p. 10
Characterisation	p. 11
Characterisation Using Gravimetric Preparation Data	p. 11
Characterisation Using a Primary (Definitive) Method	p. 12
Characterisation Using Independent Measurement Methods	p. 12
Characterisation by Inter-laboratory Studies	p. 12
Preparation of the Certification Report and Certificate	p. 13
References	p. 14
Simple Statistics for Users of CRMs	p. 15
Rules for Collecting Data from CRMs	p. 15
Concepts of Trueness, Precision and Accuracy	p. 17
Number of Required Replicates	p. 19
Detection of Outliers	p. 20
Assessment of Precision	p. 23
Assessment of Bias	p. 24
Converting Expanded Uncertainties into Standard Uncertainties	p. 25
Using CRMs to Detect other Forms of Bias	p. 25
Some Assumptions Behind Significance Testing	p. 26
t-Tests	p. 27
The F-test	p. 28
Using Statistical Software (What Is a p-Value?)	p. 31
Concepts of Measurement Uncertainty	p. 31
Principles of Least Squares Linear Regression	p. 32
Least Squares Linear Regression Statistics	p. 33
Confidence Intervals	p. 37
Extrapolation and Interpolation	p. 38
Bias, Leverage and Outliers	p. 39
References	p. 40
The Use of CRMs for Instrument Calibration	p. 41
Instrument Calibration	p. 41
Examples of CRMs Used for Instrument Calibration	p. 42
A Note on Terminology	p. 42
Pure Substance with a Documented Purity Value	p. 43
Pure Substance with a Documented Physical Property	p. 43
A Solution of a Substance with a Documented Concentration Value	p. 44
A Solution of a Substance with a Documented Property Value	p. 44
A Mixture of a Substance in a Solid Matrix with a Documented Concentration Value	p. 45
A Mixture of a Substance in a Gaseous Matrix with a Documented Concentration Value	p. 45
Instrument Calibration as Part of the Analytical Process	p. 46
Sample Matrix Effects	p. 46
The Accuracy Required in the Calibration Procedure	p. 47
Choosing a CRM for Use as a Calibration Standard	p. 49
Documentation for the CRM	p. 49
The Magnitude and Uncertainty of the Property Values	p. 50
How the Property Value Is Characterised	p. 51
The Traceability of the Property Value	p. 52
Physical/Chemical Form--Pure Substance or Matrix Material?	p. 53
Storage Requirements and Shelf Life/Expiry Date	p. 55
The Preparation of a Calibration Solution using a CRM	p. 55
Calibration Models	p. 59
Calibration Model 1	p. 59
Calibration Model 2	p. 60
Calibration Model 3	p. 60
Calibration Model 4	p. 61
Experimental Investigation of the Linear Calibration Model	p. 63
Experimental Conditions	p. 63
Instrument Stability	p. 64
Choice of CRMs	p. 64
Range of Property Values to be Covered	p. 64
Number of Calibration Points to be Obtained	p. 64
Spacing of the Calibration Points	p. 65
Number of Replicate Measurements	p. 65
Treatment of Results	p. 65
Using Linear Regression to Calculate the Calibration Line	p. 67
Combining Calibration Uncertainty with Analytical Uncertainty	p. 71
Assumptions in the Use of Linear Regression	p. 72
Abridged Methods of Calibration	p. 75
Single Point Calibration	p. 75
Two Point Calibration	p. 75
Uncertainty of Single Point and Two Point Calibrations	p. 76
Calibration by Bracketing	p. 77
Matrix Effects and Calibration	p. 77
Sample Dilution	p. 78
Matrix Matching	p. 78
Standard Additions	p. 78
Detection of Non-Linearity	p. 80
References	p. 84
Use of CRMs for Assessing the Accuracy of Analytical Data	p. 85
The Importance of CRMs in Routine Analysis	p. 85
The Selection of Matrix CRMs	p. 86
Documentation for the CRM	p. 86
Physical/Chemical Form	p. 86
Documented Property Values	p. 87
Uncertainty of the Documented Property Values	p. 87
Storage Requirements and Shelf Life/Expiry Date	p. 87
Quantity Taken for Analysis	p. 88
The Number of Different Matrix CRMs to be Used	p. 88
Principles Involved in Assessing the Accuracy of Routine Data	p. 88
What Is Accuracy?	p. 88
Procedures for the Assessment of the Precision of a Measured Result on a Matrix CRM	p. 89
The Rationale for Combining s[subscript b] and s[subscript w]	p. 90
Is the Within-laboratory Precision Acceptable?	p. 91
How Is a Value for the Bias Calculated?	p. 92
Issues Involved in Assessing the Accuracy of Routine Data	p. 94
Should a Result Obtained on a Matrix CRM Lie Within the Uncertainty Range of the Documented Reference Value?	p. 94
When Is the Uncertainty of the CRM Important?	p. 95
What is the Uncertainty of the Bias Estimate?	p. 97
What Is the Bias Detection Limit?	p. 98
Why Is the Bias Detection Limit (3.7[sigma]) Greater than the Acceptability Criterion of 2[sigma]?	p. 101
How May a Fitness-for-Purpose Criterion be Used to Calculate Acceptability Limits?	p. 101
Action to Take When a Bias Is Detected	p. 103
Check the Calibration Standards	p. 103
Check Other Possible Sources of Bias	p. 103
Check the Precision of the Measurements	p. 104
Apply a Correction Factor?	p. 105
References	p. 105
Use of CRMs in Method Validation and Assessing Measurement Uncertainty	p. 106
What Is Method Validation?	p. 106
Why Is Method Validation Necessary?	p. 107
When Do You Validate a Method?	p. 108
How Do You Validate a Method?	p. 108
Method Performance Parameters	p. 109
The Tools of Method Validation	p. 110
The Role of CRMs in Method Validation	p. 111
What is Meant by Method Accuracy, Bias and Trueness?	p. 111
Measuring Bias Against CRMs	p. 112
How Bias Is Normally Expressed	p. 113
Measuring Bias Against a Reference Method	p. 113
Statistical Treatment of Results from a Study of Bias: Comparison with a Certified or Reference Value	p. 114
Statistical Treatment of Results from a Study of Bias: Comparison with a Reference Method	p. 116
Using Bias Information	p. 118
Use of CRMs in Estimating Method Recovery and Measurement Uncertainty	p. 118
Outline of Method for the Determination of Vitamin A and Vitamin E in Infant Formula	p. 119
Precision Study	p. 119
Bias (Recovery) Study and its Associated Uncertainty	p. 120
Estimating R[subscript m] and u(R[subscript m]) Using a Representative CRM	p. 121
Estimating the Contribution of R[subscript m] to u(R)	p. 122
Calculation of R[subscript s] and u(R[subscript s]) from Spiking Studies	p. 124
Calculating R and u(R)	p. 125
Calculation of Combined Standard and Expanded Uncertainties	p. 126
Expanded Uncertainty	p. 128
Summary	p. 130
References	p. 130
List of Reference Material Producers	p. 131
Statistical Tables	p. 136
Subject Index	p. 143
Table of Contents provided by Syndetics. All Rights Reserved.

Applications of Reference Materials in Analytical Chemistry

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