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    STP of Cobalt Sulfate BP

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    bejoykarim2022
    This document outlines the standard test procedure for analyzing the active ingredient cobalt sulfate. It describes 4 tests: 1) Appearance - observing a sample visually, 2) Identification - using chemical reactions to confirm the presence of cobalt and sulfate ions, 3) Solubility - checking solubility in water, 4) Heavy metals - using a colorimetric method to check for presence of lead. It also describes an assay method to titrate a cobalt sulfate sample against EDTA to determine the percentage of active ingredient. The procedure was approved by the quality assurance manager at Shinil Pharma Ltd.

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    STP of Cobalt Sulfate BP

    Uploaded by

    bejoykarim2022
    229 views2 pages
    This document outlines the standard test procedure for analyzing the active ingredient cobalt sulfate. It describes 4 tests: 1) Appearance - observing a sample visually, 2) Identification - using chemical reactions to confirm the presence of cobalt and sulfate ions, 3) Solubility - checking solubility in water, 4) Heavy metals - using a colorimetric method to check for presence of lead. It also describes an assay method to titrate a cobalt sulfate sample against EDTA to determine the percentage of active ingredient. The procedure was approved by the quality assurance manager at Shinil Pharma Ltd.

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    This document outlines the standard test procedure for analyzing the active ingredient cobalt sulfate. It describes 4 tests: 1) Appearance - observing a sample visually, 2) Identification - using chemical reactions to confirm the presence of cobalt and sulfate ions, 3) Solubility - checking solubility in water, 4) Heavy metals - using a colorimetric method to check for presence of lead. It also describes an assay method to titrate a cobalt sulfate sample against EDTA to determine the percentage of active ingredient. The procedure was approved by the quality assurance manager at Shinil Pharma Ltd.

    Copyright:

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

    STP of Cobalt Sulfate BP

    Uploaded by

    bejoykarim2022
    This document outlines the standard test procedure for analyzing the active ingredient cobalt sulfate. It describes 4 tests: 1) Appearance - observing a sample visually, 2) Identification - using chemical reactions to confirm the presence of cobalt and sulfate ions, 3) Solubility - checking solubility in water, 4) Heavy metals - using a colorimetric method to check for presence of lead. It also describes an assay method to titrate a cobalt sulfate sample against EDTA to determine the percentage of active ingredient. The procedure was approved by the quality assurance manager at Shinil Pharma Ltd.

    Copyright:

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

    SHINIL Pharma Ltd.

    B K Bari, Mirzapur, Gazipur.

    Standard Test Procedure (Active Ingredient)


    Material Name Cobalt Sulfate BP Material Code RA- C04
    Revision No. 01 STP No. STP- RA- C04
    Effective Date October 17, 2021 Review Date October 16, 2024
    1.0 APPEARANCE :
    Take 1 g of test sample in watch glass and observe visually with white background.

    2.0 IDENTIFICATION :
    A. Reaction of Cobalt: Take 5.0 mg sample in a test tube add 2-3 drop concentrated Hydrochloric acid.
    A Blue color is produce.

    B. Reaction of Sulfate: Take 50 mg sample in a test tube dissolve it with 20 ml purified water then add
    2 ml concentrated hydrochloric acid & 5 ml barium chloride solution. A White precipitate is produce.

    3.0 SOLUBILITY
    Take 1.0 of the test sample in a test tube add 10 ml water into this test tube respectively. Shake
    properly.
    4.0 HEAVY METALS :
    Reagents:
    1) Acetate Buffer pH 3.5 (Buffer solution pH 3.5): Dissolve 25 g of ammonium acetate in 25 ml of
    water and add 38 ml of 7M hydrochloric acid. Adjust the pH to 3.5 with either 2M hydrochloric acid or
    6M ammonia and dilute to 100 ml with water.
    2.Thioacetamide Reagent: Add 1 ml of a mixture of 15 ml of 1M sodium hydroxide, 5 ml of water and
    20 ml of glycerol (85%) to 0.2 ml of thioacetamide solution, heat in a water bath for 20 seconds, cool
    and use immediately.
    3) Lead Standard Solution (0.1% Pb): Dissolve 0.400 g of lead (II) nitrate in sufficient water to produce
    250.0 ml.
    4) Lead Standard Solution (100 ppm Pb): Dilute 1 volume of lead standard solution (0.1% Pb) to 10
    volumes with water immediately before use.
    5) Lead Standard Solution (10 ppm Pb): Dilute 1 volume of lead standard solution (100 ppm Pb) to 10
    volumes with water immediately before use.
    6) Lead Standard Solution (1 ppm Pb): Dilute 1 volume of lead standard solution (10 ppm Pb) to 10
    volumes with water immediately before use.
    Test Solution: Dissolve 1.0 g of the substance to be examined in 17 ml of acetone and dilute with
    water. Take 12 ml of this solution and 2 ml of acetate buffer pH 3.5 mix, add 1.2 ml of Thioacetamide
    Reagent and allow to stand for 2 minutes.
    Result: Any brown color produced is not more intense than that of obtained by treating in this same
    manner a mixture of 10 ml of lead standard solution (10 ppm).
    5.0 ASSAY:
    Take about 100 mg cobalt sulphate test sample in a 100 ml conical flask add 20 ml purified water & 500
    mg Hexamine buffer reagent above conical flask, shake & mix well. Add 0.2 ml of xylenol orange
    indicator solution into the conical flask. Titrate the sample solution against 0.05 M EDTA solution until

    Prepared By Checked By Approved By

    Md. Rasheduzzaman Bejoy Karim Md. Mahabub Alam


    Officer, Quality Control Senior Officer, PD Manager, Quality Assurance
    Page no. 1 of 2
    SHINIL Pharma Ltd.
    B K Bari, Mirzapur, Gazipur.

    Standard Test Procedure (Active Ingredient)


    Material Name Cobalt Sulfate BP Material Code RA- C04
    Revision No. 01 STP No. STP- RA- C04
    Effective Date October 17, 2021 Review Date October 16, 2024
    the color changes from red to yellow end point.
    1 ml of 0.05M EDTA is equivalent to 14.055
    mg of CoSO4. 7H2O

    V x F x 14.055 x 100
    Calculation = ----------------------------
    Wu
    = --------------------- % (As CoSO 4. 7H2O )
    Here
    V= Volume required for titration
    F= Factor of 0.05 M EDTA
    Wu=Sample weight taken in mg

    Potency (As CoSO 4. 7H2O )


    Calculate the potency of Cobalt = ------------------------------------------
    4.77

    = ----------------- % (As Cobalt)

    List of Distribution
    1) Quality Assurance
    2) Product Development
    3) Quality Control
    4) Commercial

    Prepared By Checked By Approved By

    Md. Rasheduzzaman Bejoy Karim Md. Mahabub Alam


    Officer, Quality Control Senior Officer, PD Manager, Quality Assurance
    Page no. 2 of 2

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