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Quality Standards For Laboratory Water, ISO, ASTM, CLSI, USP & EP.

Here below we collected and put together various quality standards for laboratory water with parameter and controls for your quick reference, so far the followings are covered:

ASTM Standards for Laboratory Reagent Water (ASTM D1193-99e1)

Measurement (Unit)Type IType IIType IIIType IV
Resistivity (MΩ-cm)> 18> 1.0> 4.0> 0.2 (200KΩ)
Conductivity (µS/cm)< 0.056< 1.0< 0.25< 5.0
pH at 25˚CN/AN/AN/A5.0 – 8.0
Total Organic Carbon (TOC) ppb or µg/L< 50< 50< 200no limit
Sodium (ppb or µg/L)< 1< 5< 10< 50
Chloride (ppb or µg/L)< 1< 5< 10< 50
Silica (ppb or µg/L)< 3< 3< 500no limit
ASTM standards are further subdivided into A, B, and C which is to be used in conjunction with type I, II, III, or IV water above when bacteria level needs to be controlled.

Additional ASTM Sub-Standards for Laboratory Reagent Water

Measurement (Unit)Type AType BType C
Heterotrophic Bacteria Count (CFU/ml)< 1< 10< 1000
Endotoxin (units per ml)< 0.03< 0.25not applicable
What Is Ultrapure Water?
InviPure LabGen Type 1 Water System

ISO 3696:1987, Standard Of Water For Analytical Laboratory Use

ParameterGrade 1Grade 2Grade 3
Conductivity µS/cm (temp corrected)< 0.1< 1< 5
pH at 25 °CN/AN/A5.0 – 7.0
Oxidizable matter Oxygen (02) content mg/LN/A< 0.08< 0.4
Absorbance at 254 nm and 1 cm optical path length, absorbance units< 0.001< 0.01N/A
Residue after evaporation on heating at 110 °C mg/kgN/A< 1< 2
Silica (Si02) mg/L< 0.01< 0.02N/A

CLSI-CLRW Guidelines

ContaminantParameter and UnitType 3Type 2Type 1CLRW
IonsResistivity (MΩ-cm)> 0.05 (50 KΩ)> 1> 18> 10
OrganicsTotal Organic Carbon (TOC) ppb< 200< 50< 10< 500
Pyrogens(Eu/ML)N/AN/A< 0.03—
ParticlesParticles > 0.2 µm (units/mL)N/AN/A< 1 ***
ColloidsSilica (ppb)< 1000< 100< 10—
BacteriaBacteria (cfu/mL)< 1000< 100< 1< 10
* 0.22 µ filtration required
** 0.22 µ filtration included
CLSI: formerly known as NCCLS (US National Committee for Clinical Laboratory Standards)
CLRW: Clinical Laboratory Reagent Water

USP & EP Standards

PropertiesUSP
Purified Water		USP
Injection & ‘Highly Purified Water’		EP
Sterile & IV Water
Nitrates (ppm)N/AN/A< 0.2
Heavy Metals (ppm)N/AN/A< 0.1
Conductivity (µS/cm)< 1.3 @ 25 °C< 1.3 @ 25 °C< 1.1 @ 20 °C
Total Organic Carbon (TOC) ppb or µg/L< 500*< 500*< 500
Bacteria (guideline)< 100 cfu/ml< 10 cfu/100ml< 10 cfu/100ml
Endotoxin (EU/ml)N/A0.25 EU/ml—
*Or pass oxidisable substance test

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InviPure LabPrim Ultrapure Water System
InviPure LabUni Ultrapure Water System
InviPure LabGen Type 1 Water System

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