TECHNICAL BRIEF

High Purity Water

Requirements for Laboratory
A Quick Reference Guide to NCCLS/CAP, ASTM, ISO, USP and
Semi Standards and Guidelines
Pure water is required in
virtually all segments of
industry - pharmaceuticals,
microelectronics, and
chemicals, to name a few. It is
also essential in research,
clinical, analytical and hospital
laboratories. Application are
varied: from simple needs like
general reagent preparation
and glassware washing to
more complex applications,
such as mammalian cell
culture, electrophoresis gel
prep, sensitive instrument
analyses, in vitro fertilization,
and clinical analyzer needs.
Many of these applications
require water that meets or
exceeds guidelines set forth by
organizations suchs as the
College of American
Pathologist (CAP), the
American Society of Testing
and Material (ASTM), and the
United States Pharmacopoeia
(USP). The standards are
summarized in this technical
brief.

NCCLS/CAP Reagent Specifications

Water Type
Maximum Bacterial Content,
colony forming units per mL
(cfu/ml)
pH
Minimum Resistivity
(Mohm-cm at 25 C
Maximum Silicate
(mg/L SiO2
Particulate Matter
Organic Contaminants

I
10

II
1000

III *
N.S.

N.S.
10

N.S.
1.0

5.0 - 8.0
0.1

0.05

0.1

0.1

0,22 m
filter
Activated
2
Carbon

N.S.

N.S.

N.S.

N.S.

N.S. = Not Specified

* Water produced by Ion Exchangers NOION AQUA with Amberlite MB20
and SR-1 Resin from ROHM&HAAS

ASTM Water Specifications

Water Type
Electrical Resistivity, minimum
(Mohm-cm compensated to 25
C)
Total Organic Carbon
Sodium, maximum (ppb)
Chlorides, maximum (ppb)
Total Silica, maximum (ppb)
Water Type
Maximum Bacteria Count
(cfu/mL)
Pyrogens, Endotoxin Units/mL
N.A. = Not Applicable

I
18.0

II
1.0

III
0.25

10
1
1
3
A
10/1000 mL

50
5
5
3
B
10/100 mL

200
10
10
500
C
100/10 mL

< 0.03

<0.25

N.A.

Source Preparation and Testing of Reagent Water in the Clinical

Laboratory, Second Editions, NCCLS Document C3-A2, Vol.11, No. 13,
August 1991.
Reagent Water Preparations, College of American Pathologists, 1985.
2
Not required by CAP

NOION AQUA

International Organization for Standardization

Water Type
pH value at 25C
Electrical Conductivity
mSiemens/m at 25 C
Oxydable Matter Oxygen (O)
content mg/L, maximum
Absorbance at 254 nm and 1 cm
optical path length abosrbance
units, maximum
Residue after Evaporation on
heating at 110 C mg/kg, max.)
Silica (SiO2) content mg/L, max.
N.A. = Not Applicable
N.S. = Not Specified

Grade I
4
N.A.
5
0.01

Grade II
4
N.A.
5
0.1

Grade III *
5.0 to 7.5
0.5

0.08

0.4

0.001

0.01

N.S.

N.A.

0.01

0.02

N.S.

N.A.

* Water produced by Ion Exchangers NOION AQUA with Amberlite

MB20 and SR-1 Resin from ROHM&HAAS

USP (United States Pharmacopoeia) XXII and XXIII

Purified Water
pH
Chloride (mg/L)
Sulfate (mg/L)
Ammonia (mg/L)
Calcium (mg/L)
Carbon Dioxyde (mg/L)
Heavy Metals (mg/L)
Oxydizable Substances

USP XXII
5.0 - 7.0
0.5
1.0
0.03
1.0
5.0
0.1 as Cu
Pass USP KMnO4
Test
Total Solids (mg/L)
10.0
Total Organic Carbon (TOC)
N.S.
Conductivity
N.S.
Pyrogen, Endotoxin Units/mL
N.S.
**Replaced by conductivity measurement
***Replaced by TOC measurement
**** Water for Injection

Residue (ppm) batch

USP XXIII
Unchanged
Eliminated**
Eliminated**
Eliminated**
Eliminated**
Eliminated**
Eliminated**
Eliminated***
Eliminated**
500 ppb
1,25 S/cm
< 0.025****

0.1

Ions (ppb) by Ion Chromatography

Source: Water for analytical laboratory use - Specification and test

methods, ISO 3696, 1987 (E)
4
Because of the difficulties associated with measurement of the pH value of
high-purity water, and the doubtful significance of the value obtained, limits
for the pH of grade 1 and grade 2 water have not been specified
5
The value of conductivity for grade 1 and grade 2 water apply to freshly
prepared water; during storage, it is possible for contaminants such as
atmospheric carbon dioxide and alkalis from glass containers to be
dissolved, leading to changes in conductivity.
6
A limit for oxydable matter and residue after evaporation for grade 1 water
is not specified because of the difficulty of testing for compliance at this level
of purity. The quality of grade 1 water is, however, assured by compliance
with the other requirements and by its method of preparation.

NOION AQUA