Applications of Reference Materials in Analytical Chemistry

, by Roper, Peter; Burke, Shaun; Lawn, Richard; Barwick, Vicki; Walker, Ron

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ISBN: 9780854044481 | 0854044485
Cover: Hardcover
Copyright: 12/1/2001

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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.

Introduction

(7)

Certified Reference Materials and the VAM Principles

(1)

Definitions and Hierarchy of Reference Materials

(2)

Types of Reference Material

(1)

Uses of Reference Materials in Analytical Chemistry

(1)

Interpretation of Results Obtained with CRMs

(1)

Availability of Reference Materials

(1)

Quality of Certified Reference Materials

(1)

References

(1)

CRM Production

(7)

Assessment of Priority Needs and Confirmation of Demand

(1)

Literature Search and Project Plan

(1)

Raw Material Selection and Processing

(1)

Homogeneity Testing

(1)

Stability Testing

(1)

Characterisation

(2)

Characterisation Using Gravimetric Preparation Data

(1)

Characterisation Using a Primary (Definitive) Method

(1)

Characterisation Using Independent Measurement Methods

(1)

Characterisation by Inter-laboratory Studies

(1)

Preparation of the Certification Report and Certificate

(1)

References

(1)

Simple Statistics for Users of CRMs

(26)

Rules for Collecting Data from CRMs

(2)

Concepts of Trueness, Precision and Accuracy

(2)

Number of Required Replicates

(1)

Detection of Outliers

(3)

Assessment of Precision

(1)

Assessment of Bias

(1)

Converting Expanded Uncertainties into Standard Uncertainties

(1)

Using CRMs to Detect other Forms of Bias

(6)

Some Assumptions Behind Significance Testing

(1)

t-Tests

(1)

The F-test

(3)

Using Statistical Software (What Is a p-Value?)

(1)

Concepts of Measurement Uncertainty

(1)

Principles of Least Squares Linear Regression

(8)

Least Squares Linear Regression Statistics

(4)

Confidence Intervals

(1)

Extrapolation and Interpolation

(1)

Bias, Leverage and Outliers

(1)

References

(1)

The Use of CRMs for Instrument Calibration

(44)

Instrument Calibration

(1)

Examples of CRMs Used for Instrument Calibration

(4)

A Note on Terminology

(1)

Pure Substance with a Documented Purity Value

(1)

Pure Substance with a Documented Physical Property

(1)

A Solution of a Substance with a Documented Concentration Value

(1)

A Solution of a Substance with a Documented Property Value

(1)

A Mixture of a Substance in a Solid Matrix with a Documented Concentration Value

(1)

A Mixture of a Substance in a Gaseous Matrix with a Documented Concentration Value

(1)

Instrument Calibration as Part of the Analytical Process

(3)

Sample Matrix Effects

(1)

The Accuracy Required in the Calibration Procedure

(2)

Choosing a CRM for Use as a Calibration Standard

(6)

Documentation for the CRM

(1)

The Magnitude and Uncertainty of the Property Values

(1)

How the Property Value Is Characterised

(1)

The Traceability of the Property Value

(1)

Physical/Chemical Form - Pure Substance or Matrix Material?

(2)

Storage Requirements and Shelf Life/Expiry Date

(1)

The Preparation of a Calibration Solution using a CRM

(4)

Calibration Models

(4)

Calibration Model 1

(1)

Calibration Model 2

(1)

Calibration Model 3

(1)

Calibration Model 4

(2)

Experimental Investigation of the Linear Calibration Model

(4)

Experimental Conditions

(1)

Instrument Stability

(1)

Choice of CRMs

(1)

Range of Property Values to be Covered

(1)

Number of Calibration Points to be Obtained

(1)

Spacing of the Calibration Points

(1)

Number of Replicate Measurements

(1)

Treatment of Results

(2)

Using Linear Regression to Calculate the Calibration Line

(4)

Combining Calibration Uncertainty with Analytical Uncertainty

(1)

Assumptions in the Use of Linear Regression

(3)

Abridged Methods of Calibration

(2)

Single Point Calibration

(1)

Two Point Calibration

(1)

Uncertainty of Single Point and Two Point Calibrations

(1)

Calibration by Bracketing

(1)

Matrix Effects and Calibration

(3)

Sample Dilution

(1)

Matrix Matching

(1)

Standard Additions

(2)

Detection of Non-Linearity

(4)

References

(1)

Use of CRMs for Assessing the Accuracy of Analytical Data

(21)

The Importance of CRMs in Routine Analysis

(1)

The Selection of Matrix CRMs

(2)

Documentation for the CRM

(1)

Physical/Chemical Form

(1)

Documented Property Values

(1)

Uncertainty of the Documented Property Values

(1)

Storage Requirements and Shelf Life/Expiry Date

(1)

Quantity Taken for Analysis

(1)

The Number of Different Matrix CRMs to be Used

(1)

Principles Involved in Assessing the Accuracy of Routine Data

(6)

What Is Accuracy?

(1)

Procedures for the Assessment of the Precision of a Measured Result on a Matrix CRM

(1)

The Rationale for Combining sb and sw

(1)

Is the Within-laboratory Precision Acceptable?

(1)

How Is a Value for the Bias Calculated?

(2)

Issues Involved in Assessing the Accuracy of Routine Data

(9)

Should a Result Obtained on a Matrix CRM Lie Within the Uncertainty Range of the Documented Reference Value?

(1)

When Is the Uncertainty of the CRM Important?

(2)

What Is the Uncertainty of the Bias Estimate?

(1)

What Is the Bias Detection Limit?

(3)

Why Is the Bias Detection Limit (3.7σ) Greater than the Acceptability Criterion of 2σ?

101

(1)

How May a Fitness-for-Purpose Criterion be Used to Calculate Acceptability Limits?

101

(2)

Action to Take When a Bias Is Detected

103

(2)

Check the Calibration Standards

103

(1)

Check Other Possible Sources of Bias

103

(1)

Check the Precision of the Measurements

104

(1)

Apply a Correction Factor?

105

(1)

References

105

(1)

Use of CRMs in Method Validation and Assessing Measurement Uncertainty

106

(25)

What Is Method Validation?

106

(1)

Why Is Method Validation Necessary?

107

(1)

When Do You Validate a Method?

108

(1)

How Do You Validate a Method?

108

(1)

Method Performance Parameters

109

(1)

The Tools of Method Validation

110

(1)

The Role of CRMs in Method Validation

111

(7)

What is Meant by Method Accuracy, Bias and Trueness?

111

(1)

Measuring Bias Against CRMs

112

(1)

How Bias Is Normally Expressed

113

(1)

Measuring Bias Against a Reference Method

113

(1)

Statistical Treatment of Results from a Study of Bias: Comparison with a Certified or Reference Value

114

(2)

Statistical Treatment of Results from a Study of Bias: Comparison with a Reference Method

116

(2)

Using Bias Information

118

(1)

Use of CRMs in Estimating Method Recovery and Measurement Uncertainty

118

(12)

Outline of Method for the Determination of Vitamin A and Vitamin E in Infant Formula

119

(1)

Precision Study

119

(1)

Bias (Recovery) Study and its Associated Uncertainty

120

(1)

Estimating Rm and u(Rm) Using a Representative CRM

121

(1)

Estimating the Contribution of Rm to u(R)

122

(2)

Calcualtion of Rs and u(Rs) from Spiking Studies

124

(1)

Calculating R and u(R)

125

(1)

Calculation of Combined Standard and Expanded Uncertainties

126

(2)

Expanded Uncertainty

128

(2)

Summary

130

(1)

References

130

(1)

Annex A List of Reference Material Producers

131

(5)

Annex B Statistical Tables

136

(7)

Subject Index

143

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Applications of Reference Materials in Analytical Chemistry

Summary

Table of Contents

Supplemental Materials