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    Pure Water

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    jokonudi
    The document outlines specifications for different types and grades of reagent water from organizations like ASTM, USP, and CLSI. It provides specifications for metrics like conductivity, organic compounds, bacteria levels, and endotoxins for reagent water types I-IV from ASTM and CLSI.

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    Pure Water

    Uploaded by

    jokonudi
    40 views1 page
    The document outlines specifications for different types and grades of reagent water from organizations like ASTM, USP, and CLSI. It provides specifications for metrics like conductivity, organic compounds, bacteria levels, and endotoxins for reagent water types I-IV from ASTM and CLSI.

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    The document outlines specifications for different types and grades of reagent water from organizations like ASTM, USP, and CLSI. It provides specifications for metrics like conductivity, organic compounds, bacteria levels, and endotoxins for reagent water types I-IV from ASTM and CLSI.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    40 views1 page

    Pure Water

    Uploaded by

    jokonudi
    The document outlines specifications for different types and grades of reagent water from organizations like ASTM, USP, and CLSI. It provides specifications for metrics like conductivity, organic compounds, bacteria levels, and endotoxins for reagent water types I-IV from ASTM and CLSI.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    of 1

    ASTM® Reagent Water Specifications

    CLSI® (formerly NCCLS) Reagent Water Specifications


    USP® 30 Pharmaceutical Grade Water Standard

    UNITED STATES PHARMACOPOEIA 30 STANDARDS


    USP 30 Pharmaceutical Grade Water

    Organics . . . . . . . . . . . . . . . . . . . . . . . . . . <0.5 ppm TOC


    Conductivity . . . . . . . . . . . . . . . . . . . . . . . <1.3 µS/cm at 25°C in-line measurement**
    Endotoxin by LAL
    Purified Water . . . . . . . . . . . . . . . . . . . . No specification
    WFI . . . . . . . . . . . . . . . . . . . . . . . . . . . . <0.25 EU/mL
    Bacteria (guideline only)
    Purified Water . . . . . . . . . . . . . . . . . . . . <100 cfu/mL
    WFI . . . . . . . . . . . . . . . . . . . . . . . . . . . . <10 cfu/100 mL

    **from equivalent values from USP Table for Conductivity Limits as a Function of Temperature.

    AMERICAN SOCIETY FOR TESTING AND MATERIALS


    Standard Specifications for Reagent Water
    ASTM Type I II III IV

    Conductivity @ 25°C (micromhos/cm) . . . . . . . . . . 0.056 . . . . . . 1.0 . . . . . . . 0.25 . . . . . . . . 5.0


    Resistivity @ 25°C (Megohms-cm). . . . . . . . . . . . . 18 . . . . . . . . 1.0 . . . . . . . 4.0 . . . . . . . . . 0.2
    Total Silica (µg/L) . . . . . . . . . . . . . . . . . . . . . . . . . . 3 . . . . . . . . 3. . . . . . . .. 500 . . . . . . . . . –
    Total Organic Carbon (µg/L) . . . . . . . . . . . . . . . . . . 100 . . . . . . . 50. . . . . . . . 200 . . . . . . . . . –
    Chlorides (µg/L) . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 . . . . . . . . . 5. . . . . . . . . 10 . . . . . . .. . . 50
    Sodium (µg/L) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 . . . . . . . . . 5. . . . . . . . . 10 . . . . . . . . . . 50
    pH* . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . – . . . . . . . . . –. . . . . . .. . – . . . . . . . . 5.0-8.0

    Type A Type B Type C


    Max Heterotropic Bacteria Count . . . . . . . . . . . . . . 10/1000 mL. . . 10/100 mL. . . 100/10 mL
    Endotoxin, EU/mL . . . . . . . . . . . . . . . . . . . . . . . . . . < 0.03 . . . . . . . 0.25 . . . . . . . . N/A

    *The measurement of pH in Type I, II, and III reagent water has been eliminated because these grades of water do not
    contain constituents in sufficient quantity to alter pH.
    CLSI (CLINICAL LABORATORY STANDARDS INSTITUTE)*
    Clinical Laboratory Reagent Water (CLRW)
    CLSI
    Resistivity @ 25°C . . . . . . . . . . . . . . . . . . . . . . . . . 10
    (megohms-cm)
    Conductivity @ 25°C . . . . . . . . . . . . . . . . . . . . . . . 0.1
    (micromhos/cm)
    Bacterial Growth (cfu/mL) . . . . . . . . . . . . . . . . . . . . 10
    Organics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . <500 ppba​
    Particulate Matter . . . . . . . . . . . . . . . . . . . . . . . . . . 0.22 µm Filtera​
    a​
    This specification is a process specification, and not measured by the end-user.
    *​Formerly NCCLS (National Committee for Clinical Laboratory Standards).

    9016 Oak Street., Vancouver, BC V6P 4B9 604-677-6777 Fax 264-9777 ​www.Filterco.net

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