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Yellow Dye
  1. #1
    svento is offline New Member
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    Dec 2007
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    Default Yellow Dye

    Does anyone know what the difference is between yellow dye #5 and yellow dye #10? My husband is allergic to #5 but has been prescribed a medication which contains #10.

    Thank You

  2. #2
    bhermeier is offline New Member
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    Feb 2009
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    Default yellow food dye #10

    I also would like to know the answer to that question. I, too, am allergic to #5 and am now taking a medication with #10 in it.

  3. #3
    bhermeier is offline New Member
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    Feb 2009
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    Default yellow food dye #10 or quinoline yellow

    Found this on the web

    INTERNATIONAL REGULATORY STATUS OF
    D&C YELLOW #10 DYE AND LAKE http://www.colorcon.com/literature/r...20Issues_0.pdf

    D&C Yellow #10 and Quinoline Yellow (E104) are both sometimes referred to as Quinoline Yellow which has created much controversy when companies are trying to formulate global products. These colors are two different chemicals and cannot be interchanged. Unfortunately, due to the regulatory issues listed below, these differences create challenges when developing products that are to be marketed globally. This usually results in the need for multiple versions of a product which are formulated to meet regulatory requirements in specific geographic markets.

    United States: 21CFR (Part 74) lists the approved color as D&C Yellow #10. The specifications are listed in 21 CFR (Section 74.1710) which requires that the dye contain not less than 75% of the monosulfonated component and not more than 15% of the disulfonated component. Currently, D&C Yellow #10 is approved for use in Drugs and Cosmetics but is not approved for Food uses.
    ¾ Issue: This material is not acceptable for use in foods or drugs in Europe due to a difference in the specifications of the monosulfonated and disulfonated components of the dye.
    European Union: EC Directive 94/36/EC lists the approved color as Quinoline Yellow (E104). The specific purity requirements are listed in EC Directive 95/45/EC which requires that the material contain not less than 80% of the disulfonated component and not more than 15% of the mono-sulfonated component. Quinoline Yellow (E104) is approved in Europe for use in Food and Drugs.
     Therefore, by definition you cannot have a material that meets both the U.S,. and the European specifications for use in Drugs. Additionally, neither color is listed in both regions for use in foods.
    Japan: Both D&C Yellow #10 and Quinoline Yellow (E104) are NOT approved for use in foods or drugs at this time. There has not been a precedent of use of either color in a drug product which has been approved by MHW. This does not preclude the potential for use; however, significant justification data would have to be submitted to support the inclusion of these colors. This may be difficult and delay product approvals.
    Other Regions: Some countries such as Canada, Chile, Indonesia, Pakistan, etc. accept either color and both are known to be used in Australia. Others countries such as China, Brazil, Mexico, etc. do not allow for the use of D&C Yellow #10 or Quinoline Yellow (E104). It is important that the specific regulations of the target countries be evaluated before making a formulation decision. Colorcon’s International Color Regulations Guide can be helpful in providing initial guidance. These guides are available upon request.

    COLORCON
    Trade organizations such as the International Association of Color Manufacturers (IACM) are discussing these issues with International Regulators to see if there could be modifications of the regulations in the future, however, at this time, there are no proposals or petitions in place which will impact the specification situation. IACM has petitioned the FDA to broaden the acceptability of D&C Yellow #10 for food use in the
    U.S. and to make it an FD&C color. This process will probably take several years to complete.
    January 2005
    World Headquarters
    Colorcon 415 Moyer Blvd., P.O. Box 24, West Point, PA 19486-0024 Tel: 215-699-7733 Fax: 215-661-2605 Website: www.colorcon.com/pharma e-mail: info@colorcon.com
    Locations Telephone Facsimile Locations Telephone Facsimile
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    St. Laurent, QC, Canada 514-337-8341 514-337-9159
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    The information contained herein, to the best of our knowledge is true and accurate. Any recommendations or suggestions are made without warranty or guarantee, since the conditions of use are beyond our control. Any information contained herein is intended as a recommendation for use of our products so as not to infringe on any patent.
    © 2008 Colorcon, Inc. The information contained in this document is proprietary to Colorcon and may not be used or disseminated inappropriately.

  4. #4
    bhermeier is offline New Member
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    Feb 2009
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    Default yellow dye #10 and #5

    My pharmacist just told me today that both are azo chemical compositions so are related.

    Please let me know what you found out.

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