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    Pronovapure 4638 Ee Technical Information

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    Thảo Linh

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    Pronovapure 4638 Ee Technical Information

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    Thảo Linh
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    36 views2 pages

    Pronovapure 4638 Ee Technical Information

    Uploaded by

    Thảo Linh

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    © All Rights Reserved
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    PronovaPure® 46:38 EE

    Chemical names of active ingredient


    Omega-3 Fatty Acids
    Eicosapentaenoic acid (EPA)
    Docosahexaenoic acid (DHA) Eicosapentaenoic Acid EPA

    CAS-No.
    86227-47-6 EPA ethyl ester
    Docosahexaenoic Acid DHA
    81926-94-5 DHA ethyl ester

    PRD-No. Description
    30634624 PronovaPure® 46:38 EE is a light yellow fish oil ethyl
    ester concentrate.
    Articles The fish oil is obtained from anchovies, sardines
    50428341* 190 kg steel drum and mackerels (families Engraulidae, Clupeidae,
    Scombridae and Carangidae). The product is an
    * packed under inert gas ethyl ester (EE), rich in omega-3 fatty acids. The
    content of EPA (Eicosapentaenoic acid expressed
    Country of origin as EE) and DHA (Docosahexaenoic acid expressed
    Norway as EE) is min. 800 mg/g.

    30634624 | PronovaPure® 46:38 EE Page 1 of 2


    Composition Monographs and Regulations
    Ingredients in descending order of weight: PronovaPure® 46:38 EE meets the requirements
    Fish oil ethyl ester concentrate, tocopherol-rich for an omega-3 fatty acid source in most countries.
    extract* (E 306). The product complies with the Ph. Eur. monograph
    * mainly derived from soybean (from identity preserved, on Omega-3-acid ethyl esters 90 (1250). Further,
    not genetically modified origin) the product conforms to the voluntary GOED
    mono­graph in the current version.
    Solubility Fish oil ethyl ester concentrates are accepted for
    Practically insoluble in water, very soluble in use in dietary supplements in most countries.
    acetone, in ethanol (96 per cent), in heptane and in However, specific regulations on the product and
    methanol. its ingredients in the respective countries and for its
    intended use have to be observed.
    Specification
    Stability, Storage and Handling
    Assay Stored in its unopened original packaging at ambient
    conditions (0 – 25 °C), the product is stable for
    as ethyl ester Ph. Eur. 1250/2.4.29
    at least 36 months.
    EPA (Eicosapentaenoic acid) 430 – 495 mg/g The product is sensitive to oxygen, light and heat. It
    DHA (Docosahexaenoic acid) 347 – 403 mg/g should therefore be stored in the tightly sealed,
    EPA & DHA (Eicosapentaenoic 800 – 880 mg/g lightproof packaging in a cool place. Once opened,
    & Docosahexaenoic acid) it is recommended to use the remaining contents
    as quickly as possible.
    Total Omega-3 content min. 90% (w/w)

    For further information see separate document: Applications


    “Standard Specification” (not for regulatory Dietary supplements:
    purposes) available via BASF’s WorldAccount: PronovaPure® 46:38 EE is intended for use in
    https://worldaccount.basf.com (registered access). dietary supplements such as in soft gel capsules.

    Standards Note
    Produced under cGMP and HACCP principles. PronovaPure® 46:38 EE must be handled in accor-
    dance with the Material Safety Data Sheet.

    This document, or any answers or information provided herein by


    BASF, does not constitute a legally binding obligation of BASF. While
    the descriptions, designs, data and information contained herein are
    presented in good faith and believed to be accurate, it is provided for
    your guidance only. Because many factors may affect processing or
    application/use, we recommend that you make tests to determine the
    suitability of a product for your particular purpose prior to use. It does
    not relieve our customers from the obligation to perform a full inspection
    of the products upon delivery or any other obligation.
    NO WARRANTIES OF ANY KIND, EITHER EXPRESS OR IMPLIED,
    INCLUDING WARRANTIES OF MERCHANTABILITY OR FITNESS FOR
    A PARTICULAR PUR­ POSE, ARE MADE REGARDING PRODUCTS
    DESCRIBED OR DESIGNS, DATA OR INFORMATION SET FORTH, OR
    THAT THE PRODUCTS, DESIGNS, DATA OR INFORMATION MAY BE
    USED WITHOUT INFRINGING THE INTELLECTUAL PROPERTY RIGHTS
    OF OTHERS. IN NO CASE SHALL THE DESCRIPTIONS, INFORMATION,
    DATA OR DESIGNS PROVIDED BE CONSIDERED A PART OF OUR
    TERMS AND CONDITIONS OF SALE.

    November 2015

    30634624 | PronovaPure® 46:38 EE Page 2 of 2

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