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    CAA CAM specification - BP USP FCC8 E330 - 副本

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    xuân ba cao
    This document provides specifications for tri-sodium citrate and citric acid from various sources. It lists requirements such as sensory characteristics, identification tests, moisture content, purity levels, and limits for impurities like chloride, sulfate, oxalates, heavy metals, and more. The specifications are to be followed according to standards from the British Pharmacopoeia, European Pharmacopoeia, United States Pharmacopeia, and FCC.

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    Download as PDF, TXT or read online from Scribd

    CAA CAM specification - BP USP FCC8 E330 - 副本

    Uploaded by

    xuân ba cao
    141 views2 pages
    This document provides specifications for tri-sodium citrate and citric acid from various sources. It lists requirements such as sensory characteristics, identification tests, moisture content, purity levels, and limits for impurities like chloride, sulfate, oxalates, heavy metals, and more. The specifications are to be followed according to standards from the British Pharmacopoeia, European Pharmacopoeia, United States Pharmacopeia, and FCC.

    Original Description:

    Acid citric

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    This document provides specifications for tri-sodium citrate and citric acid from various sources. It lists requirements such as sensory characteristics, identification tests, moisture content, purity levels, and limits for impurities like chloride, sulfate, oxalates, heavy metals, and more. The specifications are to be followed according to standards from the British Pharmacopoeia, European Pharmacopoeia, United States Pharmacopeia, and FCC.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    141 views2 pages

    CAA CAM specification - BP USP FCC8 E330 - 副本

    Uploaded by

    xuân ba cao
    This document provides specifications for tri-sodium citrate and citric acid from various sources. It lists requirements such as sensory characteristics, identification tests, moisture content, purity levels, and limits for impurities like chloride, sulfate, oxalates, heavy metals, and more. The specifications are to be followed according to standards from the British Pharmacopoeia, European Pharmacopoeia, United States Pharmacopeia, and FCC.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    of 2

    江 苏 国 信 协 联 能 源 有 限 公 司

    JIANGSU GUOXIN UNION ENERGY CO., LTD.


    中国江苏省宜兴经济开发区热电路 1 号
    Address: No.1, Redian Road, Yixing Economic Development Zone, Jiangsu China （214203）
    E-mail: [email protected] Http://www.co-union.com
    Tel: +86-510-87124288, 87125029 Fax: +86-510-87125020, 87121020

    SPECIFICATION OF Tri-Sodium Citrate


    Item BP2012/2014/2016/EP7.0 EP9.0 USP32/USP35/USP36/USP40 FCC8/9/10 E331

    Characters（GB：Sensory
    Color: white or colorless. Status: crystal granular or powder. Smell, taste, odourless,
    requirements
    taste salty.
    ）

    Identification Pass test Pass test Pass test Pass test Pass test
    Acidity or alkalinity Pass test Pass test Pass test Pass test ／
    Clarity and Color of
    Pass test Pass test ／ ／ ／
    solution
    Moisture 11.0%～13.0% 11.0%～13.0% 10.0%～13.0% 10.0%～13.0% 10.0%～13.0%

    content 99.0%～101.0% 99.0%～101.0% 99.0%～100.5% 99.0%～100.5% ≥99.0%

    Readily Carbonisable Not exceeding Not exceeding


    ／ ／ ／
    Substances the standard the standard

    Iron ／ ／ ／ ／ ／

    Chloride ≤50ppm ≤50ppm ／ ／ ／

    Sulphate ≤150ppm ≤150ppm ／ ／ ／

    Oxalates ≤300ppm ≤300ppm ／ ／ ≤100mg/kg

    Heavy metals ≤10ppm ／ ≤10ppm ／ ／

    Arsenic ／ ／ ／ ／ ≤1mg/kg

    Lead ／ ／ ／ ≤2mg/kg ≤2mg/kg

    Mercury ／ ／ ／ ／ ≤1mg/kg

    Tartrate ／ ／ Pass test ／ ／

    Pyrogen Pass test Pass test ／ ／ ／

    2019-9-2
    江 苏 国 信 协 联 能 源 有 限 公 司
    JIANGSU GUOXIN UNION ENERGY CO., LTD.
    中国江苏省宜兴经济开发区热电路 1 号
    Address: No.1, Redian Road, Yixing Economic Development Zone, Jiangsu China （214203）
    E-mail: [email protected] Http://www.co-union.com
    Tel: +86-510-87124288, 87125029 Fax: +86-510-87125020, 87121020
    SPECIFICATION OF Of Citric Acid
    USP35/USP36/US
    Item BP2012/BP2014/EP7.0 EP9.0 USP32 USP42
    P40

    Characters（GB：Sensory
    Color: white or colorless. Status: crystal granular or powder, odourless, taste
    requirements
    very acid, citric acid monohydrate slightly weathering in dry air.
    ）

    Identification Pass test Pass test Pass test Pass test Pass test
    Clarity and Color of
    Pass test Pass test Pass test Pass test Pass test
    solution
    Anhydrous ≤1.0% ≤1.0% ≤1.0% ≤1.0% ≤1.0%
    Water
    Monohydrate 7.5%～9.0% 7.5%～9.0% 7.5%～9.0% 7.5%～9.0% 7.5%～9.0%

    Content 99.5%～100.5% 99.5%～100.5% 99.5%～100.5% 99.5%～100.5% 99.5%～100.5%

    Readily Carbonisable Not exceeding Not exceeding Not exceeding Not exceeding Not exceeding
    Substances the standard the standard the standard the standard the standard

    Calcium ／ ／ ／ ／ ／

    Chloride ／ ／ ／ ／ ／

    Anhydrous
    Sulphate ≤150ppm ≤150ppm ≤0.015% ≤0.015% ≤0.015%
    Monohydrate

    Oxalates ≤360ppm ≤360ppm ≤0.036% ≤0.036% ≤0.036%

    Heavy metals ≤10ppm ／ ≤10μg/g ≤10μg/g /

    Lead ／ ／ ／ ／ ／

    Aluminium ≤0.2ppm ≤0.2ppm ≤0.2ppm ≤0.2ppm ≤0.2ppm

    Arsenic ／ ／ ／ ／ ／

    Mercury ／ ／ ／ ／ ／

    Sulphuric acid ash content ≤0.1% ≤0.1% ≤0.1% ≤0.1% ≤0.1%


    Bacterial endotoxins ≤0.5IU/mg ≤0.5IU/mg Pass test Pass test Pass test

    2019-9-2

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