are suitable for use in most analytic laboratory procedures
Reagent grade or analytic reagent (AR)
have additional purification steps for use in specific procedures such as chromatography, immunoassays, molecular diagnostics, standardization, or other techniques that require extremely pure chemicals
ultrapure, chemically pure (CP)
Used in manufacturing drugs
United States Pharmacopeia (USP);
Used in manufacturing drugs
National Formulary (NF); and
used primarily in manufacturing and should never be used in the clinical laboratory.
technical or commercial grade
impurity limitations are not stated, and the preparation of these chemicals is not uniform.
ultrapure, chemically pure (CP)
not recommended that clinical laboratories use these chemicals for reagent preparation unless further purification or a reagent blank is included.
ultrapure, chemically pure (CP)
limitations established for this group of chemicals are based only on the criterion of not being injurious to individuals.
National Formulary (NF); and
United States Pharmacopeia (USP);
Chemicals in this group may be pure enough for use in most chemical procedures, but the purity standards they meet are not based on the needs of the laboratory and may or may not meet all assay requirements
National Formulary (NF); and
United States Pharmacopeia (USP);
A committee of the _________ established specifications for AR grade chemicals, and chemical manufacturers must either meet or exceed these requirements
American Chemical Society (ACS)
highly purified chemical that can be measured directly to have an exact known concentration and purity.
Primary standard
are used in place of ACS primary standard materials due to tolerance limitations of some biologic constituents.
SRM
made the standard reference materials
nist
NIST
National Institute of Standards and Technology
The chemical composition of these substances is certified; however, they may not have the purity of a primary standard.
Standard reference materials (SRMs)
ften used to verify calibration or accuracy/bias assessments.
Standard reference materials (SRMs)
used for linearity studies to determine the relationship between the standard’s concentration and the instrument result. This test is required when a new test or new test methodology is introduced
Standard reference materials (SRMs)
is a process that pairs an analytical signal with a concentration value of an analyte.
Calibration of an instrument
Most procedures, along with reagent and control preparation requires substantially purified water known as
reagent-grade water.
According to ________, reagent-grade water is based on its use rather than the method od purification or preparation.
CLSI or Clinical and laboratory standards institute
Categories of reagent-grade water:
Clinical laboratory reagent water (CLRW),
special reagent water (SRW),
instrument feed water,
water supplied by method manufacturer,
autoclave and wash water, and
commercially bottled purified water
____ requires laboratories to define the specific type of water required for each of its testing procedures and requires water quality testing atleast annually.
The college of american pathologists
Water quality testing routinely includes
monitoring microbial colony-forming units/ml and may include other parameters
Purified to remove almost all organic materials
distilled water