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    Master Formula Brimolol Solution

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    Sarfarazpk1
    This document provides the master formula and manufacturing process for Brimonidine Tartrate Ophthalmic Solution. The batch size is 100 liters, which yields 20,000 units. It lists the ingredients and quantities needed to produce the solution. The three part manufacturing process involves: (1) preparing the bulk solution, (2) preparing the Brimonidine Tartrate/Timolol solution, and (3) combining the solutions and adjusting pH before filtration and filling. Quality control checks and specifications are also outlined.

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    Master Formula Brimolol Solution

    Uploaded by

    Sarfarazpk1
    266 views3 pages
    This document provides the master formula and manufacturing process for Brimonidine Tartrate Ophthalmic Solution. The batch size is 100 liters, which yields 20,000 units. It lists the ingredients and quantities needed to produce the solution. The three part manufacturing process involves: (1) preparing the bulk solution, (2) preparing the Brimonidine Tartrate/Timolol solution, and (3) combining the solutions and adjusting pH before filtration and filling. Quality control checks and specifications are also outlined.

    Original Description:

    Brimolol Solution Formulation

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    This document provides the master formula and manufacturing process for Brimonidine Tartrate Ophthalmic Solution. The batch size is 100 liters, which yields 20,000 units. It lists the ingredients and quantities needed to produce the solution. The three part manufacturing process involves: (1) preparing the bulk solution, (2) preparing the Brimonidine Tartrate/Timolol solution, and (3) combining the solutions and adjusting pH before filtration and filling. Quality control checks and specifications are also outlined.

    Copyright:

    © All Rights Reserved
    Download as DOC, PDF, TXT or read online from Scribd
    Download as doc, pdf, or txt
    266 views3 pages

    Master Formula Brimolol Solution

    Uploaded by

    Sarfarazpk1
    This document provides the master formula and manufacturing process for Brimonidine Tartrate Ophthalmic Solution. The batch size is 100 liters, which yields 20,000 units. It lists the ingredients and quantities needed to produce the solution. The three part manufacturing process involves: (1) preparing the bulk solution, (2) preparing the Brimonidine Tartrate/Timolol solution, and (3) combining the solutions and adjusting pH before filtration and filling. Quality control checks and specifications are also outlined.

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    © All Rights Reserved
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    You are on page 1of 3

    Annexure-I

    Master Formula

    PRODUCT: BRIMOLOL OPHTHALMIC SOLUTION.

    BATCH SIZE: 100 LITRES (20,000 UNITS)

    S. Batch Size Remarks


    Ingredients Per ml
    No. 100 litres Specifications
    Supplier
    1. Brimonidine Tartrate 2.000 mg 200.00 gm
    Specification.

    2. Timolol Maleate 6.830 mg 683.00 gm USP

    Dibasic Sodium Phosphate


    3. 5.313 mg 513.30 gm B.P/USP
    heptahydrate
    Monobasic Sodium
    4. 5.313 mg 513.30 gm B.P/USP
    Phosphate Monohydrate

    5. Benzalkonium Chloride 0.040 mg 4.0000 gm B.P/USP

    6. Sodium Chloride 6.300 mg 630.00 gm B.P/USP

    7. Disodium Edetate 0.130 mg 13.000 gm B.P/USP

    8. Sodium Hydroxide qs qs B.P/USP

    9. Purified water q.s to make 1.00 ml 100 litres B.P/USP

    ________________ ___________________
    Production Manager Quality Control Manager
    Page 1 of 3
    PRODUCT: BRIMOLOL OPHTHALMIC SOLUTION.

    BATCH SIZE: 100 LITRES (20,000 UNITS)

    METHOD OF MANUFACTURE

    GMP CHECK LIST

    The walls, floor, ceiling lights are clean and in satisfactory condition. Ensure that
    each equipment used in the manufacturing must be thoroughly cleaned and
    properly logged. All extraneous materials including materials from previous batches
    have been removed from the area.
    Attach sterilization charts to the manufacturing record.

    PRECAUTIONS

    All operators should wear mask, rubber gloves, and uniform with sleeves tucked in
    during all process of manufacture.
    Loteprednol etabonate may cause irritation. Wear gloves, eye protection, while
    handling this material. Avoid breathing dust. Wash hand and face well before eating
    or smoking after handling this material.
    1.0 METHOD:
    The manufacturing of Brimonidine Tartrate Timolol is carried out in three parts.

    PART A (Preparation of Bulk Solution) :


    1.1 Take purified water about 90 liters in S.S mixing vessel and dissolve the
    following materials.
    Sodium Phosphate Diabasic Heptahydrate 513.30 gm
    Sodium Chloride 630.00 gm
    Disodium Edetate 0.130 gm
    1.2 Start passing nitrogen gas filtered through 0.22um Filter in the above
    solution.
    1.3 Add benzalkonium solution 4.0000 gm to the bulk solution. Rinse the
    Benzalkonium container with sufficient purified water and add the rinse to the
    bulk solution.
    1.4 Bring the temperature of bulk solution to room temperature by passing filtered
    Nitrogen gas.

    ________________ ___________________
    Production Manager Quality Control Manager
    Page 2 of 3
    PART B (Preparation of Brimonidine Tartrate / Timolol Solution) :
    1.5 Take about 5 liters fresh purified water in a glass jar., cool down to room
    temperature by passing filtered nitrogen gas. Check the temperature it
    should not exceed 30 (degree Centigrade).
    1.6 Add Brimonidine Tartrate 200 gm and Timolol Maleate 683.0 gm to the glass
    jar containing cool water and mix by passing the filtered nitrogen gas till a
    clear solution is obtained.

    PART C (Final Preparation) :

    1.7 Add the Brimonidine Tartrate + Timolol to the bulk solution. Mix under
    mitrogen atmosphere till a clear solution is resulted.
    1.8 Make up the volume with freshly purified water cooled down to 30 (Degree
    Centigrade) under nitrogen atmosphere.
    1.9 Check the pH of the solution.

    pH range : 7.2 7.6


    2.0 Adjust the pH if necessary with 1N sodium hydroxide.
    pH: ..
    Quantity of Sodium Hydroxide 1N used .
    2.1 Submit the sample to Q.A for bulk analysis.
    2.2 After Q.A satisfactory results, filter the solution through sterilized 0.22um filter
    paper under aseptic condition and collect the filtered solution in pre-sterile
    storage container.
    2.3 Perform the leak test of the filter solution.
    2.4 Fill the solution in pre-sterilized plastic bottle under aseptic condition.
    2.5 Submit the filtered bottle for chemical and stability test to Q.A.

    ________________ ___________________
    Production Manager Quality Control Manager
    Page 3 of 3

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