A - Chapter I: INTRODUCTION TO CLINICAL CHEMISTRY
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– seeks to understand the physiologic and biochemical processes occurring in normal and abnormal states
Fundamental science
– analyses performed on body fluids or tissues to provide important information for the diagnosis and treatment of disease
Applied science
LABORATORY REAGENTS: A. CHEMICALS
Analytical grade/Reagent grade chemicals United States of Pharmacopoeia and National Formulary Chemically pure/Pure grade chemicals Technical/Commercial grade
LABORATORY REAGENTS: B. STANDARDS
Primary Standards Secondary Standards Standard Reference Materials
• meet specifications set by the American Chemical Society
Analytical Grade
• of high purity and is suitable for most analytical laboratory procedures
Analytical Grade: Ultra-Pure Reagents
• Includes spectograde, nanograde and HPLC
Analytical Grade
-used to manufacture drugs
United States Pharmacopeia (USP) and National Formulary (NF)
• Less pure grade
Chemically pure (CP) / Pure Grade Chemicals
• Impurity limitations and chemical preparation are not uniform
Chemically pure (CP) / Pure Grade Chemicals
• lowest quality and should not be used for analytical work
Technical or Commercial grade
• highly purified chemicals that can be measured directly to produce a substance of exact known concentration.
Primary Standard (PS)
• used for standardization of solutions of unknown strength
Primary Standard (PS)
• stable and can be dried, preferably at 104 - 110 ̊C, without a change in composition
Primary Standard (PS)
• not hygroscopic
Primary Standard (PS)
• of lower purity with concentration determined by comparison with a primary standard
Secondary Standard
• certified by the National Bureau of Standards (NBS)
Standard Reference Materials (SRM)
• Types of Reagent Grade Water:
Distilled water Deionized water
Type I Resistivity (megaohm/cm (@ 25OC) Silicate (mg/L, as SiO2) pH Microbiologic content (CFU/mL)
10 2.0 0.1
Type II Resistivity (megaohm/cm (@ 25OC) Silicate (mg/L, as SiO2) pH Microbiologic content (CFU/mL)
0.05 0.1 1.0
Type III Resistivity (megaohm/cm (@ 25OC) Silicate (mg/L, as SiO2) pH Microbiologic content (CFU/mL)
NS NS 5 - 8 <10 103 NS
➢ Used in test methods requiring minimum interference and maximum precision and accuracy
Type I
➢ acceptable for most analytic procedures
Type II
trace metal , iron and enzyme analyses, electrolyte measurements
Type I