CLINCAL CHEMISTRY 1 • Limitations include only the fact that it

should not be injurious to individuals

• May be pure enough for use in most
chemical procedures (BUT, the purity
CHEMICALS standards are not based on the needs
of the laboratory, therefore, may or
may not meet all assay requirement

GRADES OF CHEMICAL PURITY TECHNICAL OR COMMERCIAL GRADE

1. Analytical Reagent (AR) • Are used primarily in manufacturing
2. Ultrapure, Chemically Pure (CP) and should never be used in the
3. United States Pharmacopeia (USP) clinical laboratory
4. National Formulary (NF)
5. Technical or Commercial Grade Organic reagents also have varying
grades of purity that differ from those
AR used to classify inorganic reagents.
• Specifications are provided by the These grades include a practical
American Chemical Society (ACS) grade with some impurities;
which manufacturers either meet or CP
exceed. o Approaches the purity level of
• Labels state the actual impurities for reagent grade chemicals
each chemical lot or list the maximum o Spectroscopic (spectrally pure)
allowable impurities. & Chromatographic grade
• Labels should be clearly printed with organic reagents: purity levels
the percentage of impurities present attained by their respective
and either of the following procedures
o Initials AR or o Reagent grade: certified to
o ACS, or the term contain impurities below certain
o For Laboratory Use or ACS- levels established by the ACS
Standard-Grade reference.
• Suitable for use in most analytical Other than purity as requirement, OSHA also
laboratories mandates manufacturers to indicate any
physical or biologic hazards and precautions
CP needed for the safe use, storage, and
• Have been put through additional disposal of any chemical
purification steps for use in specific
procedures such as
o Chromatography
o Atomic Absorption REFERENCE MATERIALS
o Immunoassays
o Molecular diagnostics
o Standardization, or Primary Standard: a highly purified chemical
o Other techniques that require that can be measured directly to produce a
extremely pure chemicals, substance of exact known concentration
• May carry designations of HPLC or and purity.
chromatographic on their labels.
• Impurity limitations are not stated and Standard Reference Materials (SRM)
that preparation of these chemicals is • Use in CC
not uniform • Assigned a value after careful analysis,
• Not recommended to be used by the using state-of-the-art methods and
clinical lab for reagent preparation, equipment.
unless, further purification of a reagent • Chemical composition is certified
blank is included. • May not possess the purity standards
as primary standard.
USP and NF • Verify calibration or accuracy/ bias
• Used to manufacture drugs assessments
Secondary Standard: substance of lower • Distilled Water: purified to remove
purity. Concentration is determined by almost all organic materials. Water is
comparison to a primary standard. boiled and vaporized, then,
condensed. Impurities remain in the
boiling apparatus. Distillation can be
done more than once.
WATER • Ultrafiltration and nanofiltration:
removes particulate matter,
microorganisms, any pyrogen or
• Most frequent reagent used in the Clin endotoxin.
Lab • Deionized water: has some or all ions
• The Clinical and Laboratory Standards removed, though organic materials
Institute (CLSI) classifies water into 6 may still be present. Neither pure nor
categories based on the specifications sterile.
needed for its use rather than the o Generally, purified first from
method of purification and previously treated water
preparation: o Produced using anion or cation
o Clinical Laboratory Reagent exchange resin, followed by
Water (CLRW) replacement of the removed
o Special Reagent water (SRW) ions with hydroxyl or hydrogen
o Instrument Feed Water ions.
o Water supplied by method o Excellent in removing dissolved
manufacturer ionized solids and dissolved
o Autoclave and wash water gases
o Commercially bottle purified
water
• Water purification:
o Distillation
o Ion-exchange
o Reverse osmosis
o Ultrafiltration
o UV light
o Sterilization
o Ozone treatment
• Lab needs to assess whether the water
meets the specifications needed for its
application.
• Water-monitoring parameters
o Microbiological count
o pH
o Resistivity (measure of
resistance in Ohms and
influenced by the number of
ions present)
o Silicate
o Particulate matter
o Organics
• Traditional classification of Waater
based on Purity: Type I to III
• Type I has the most stringent
requirement and is suitable for routine
lab use