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    Registration File For Immune Support Liquid

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    iloveit52252
    The document describes an immune support syrup containing echinacea and zinc. It provides details on the product description, formulation, manufacturing process, and production capacity.

    Copyright:

    © All Rights Reserved
    Download as DOC, PDF, TXT or read online from Scribd

    Registration File For Immune Support Liquid

    Uploaded by

    iloveit52252
    16 views2 pages
    The document describes an immune support syrup containing echinacea and zinc. It provides details on the product description, formulation, manufacturing process, and production capacity.

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    Registration file for Immune Support Liquid.doc

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    © © All Rights Reserved

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    The document describes an immune support syrup containing echinacea and zinc. It provides details on the product description, formulation, manufacturing process, and production capacity.

    Copyright:

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

    Registration File For Immune Support Liquid

    Uploaded by

    iloveit52252
    The document describes an immune support syrup containing echinacea and zinc. It provides details on the product description, formulation, manufacturing process, and production capacity.

    Copyright:

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

    Immune Support Syrup

    (Echinacea and Zinc Syrup)

    Product Description : Brown Color, Fruit punch flavored Syrup


    Bottle Fill Volume : 120.00 ml
    Presentation : 1 x 1’s = 1 Bottle
    No. of Bottles per Batch : 16,666 Bottles
    No. of Packs per Batch : 16,666 Packs
    Packaging Material : Liquid filled Amber glass bottle packed in
    Cardboard carton with insert
    Each 5ml Contains
    Echinacea Purpurea Ext 150.000 mg
    Zinc (as Zinc Sulphate) 3.333 mg

    Formulation:

    No. Ingredients Functions mg / unit Kg / batch


    1. Zinc Sulphate Active 14.667 5.867
    2. Echinacea purpurea extract (4% polyphenols) Active 150.000 60.000
    3. Sodium Benzoate Preservative 5.000 2.000
    4. Potassium Sorbate Preservative 5.000 2.000
    5. Sorbitol (70%) Non Crystalline Sweetener/Vehicle 2500.000 1000.000
    6. Sucralose Artificial Sweetener 3.335 1.334
    7. Glycerin Vehicle 250.000 100.000
    8. Xanthan Gum Thickening agent 12.500 5.000
    9. Propylene glycol Solubilizing agent 100.000 40.000
    10. Malic acid anhydrous Taste enhancer 10.000 4.000
    11. EDTA sodium Buffering agent 1.000 0.400
    12. Tropical Fruit Punch Flavor (BBA) Flavoring agent 5.000 2.000
    13. Black Current Flavor (BBA) Flavoring agent 5.000 2.000
    14. Simethicone Emulsion 30 % Antifoaming agent 0.500 0.200
    15. Purified Water Vehicle Q.S to 5.000ml Q.S to 2000 Liters

    Production Capacity

     One batch can be manufactured in one shift.


     Packaging of one batch can be done in one shift.

    __________________
    Head of
    Product Development

    Page 1 of 2
    Immune Support Syrup
    (Echinacea and Zinc Syrup)

    MANUFACTURING PROCEDURE

    Precautions:

    1. Follow Good Manufacturing Practices for the Manufacturing specialties.


    2. Workers directly handling the products must wear gloves and masks.
    Procedure:

    1. Mix Zinc Sulphate, Echinacea purpurea extract (4% polyphenols),Sodium


    Benzoate, Potassium Sorbate, Sorbitol (70%) Non Crystalline, Sucralose,
    Glycerin, Xanthan Gum, Propylene glycol, Malic acid anhydrous and EDTA
    sodium in Purified water

    2. Mix Tropical Fruit Punch Flavor, Black Current Flavor, Simethicone Emulsion 30
    %

    3. Makeup the volume upto 2000 Liters with Purified Water.

    4. Fill the final liquid in Amber glass bottle at 120 ml Fill volume.

    5. Sample to QA for analysis.

    6. After the release from QA, pack the filled Bottles in cardboard carton.

    Critical steps:

    1. Check the weight of all ingredients before manufacturing.

    2. Check average fill Volume after every 30 minutes during Liquid filling.

    __________________
    Head of
    Product Development

    Page 2 of 2

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