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    53 Spasmodic Tabletstablets

    Uploaded by

    Siraj Sahib
    This document provides the standard analytical procedure for testing Spasmodic Care tablets produced by Welmark Pharmaceuticals. It outlines the specifications for the core and coated tablets including description, average weight, thickness, hardness, friability, loss on drying, and disintegration time. The procedure describes the assay method using HPLC to test for the active ingredients phloroglucinol and trimethyl phloroglucinol. It also provides the dissolution test method using the specified medium and apparatus to ensure at least 75% of the drugs dissolve within 60 minutes.

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    © All Rights Reserved
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    53 Spasmodic Tabletstablets

    Uploaded by

    Siraj Sahib
    22 views6 pages
    This document provides the standard analytical procedure for testing Spasmodic Care tablets produced by Welmark Pharmaceuticals. It outlines the specifications for the core and coated tablets including description, average weight, thickness, hardness, friability, loss on drying, and disintegration time. The procedure describes the assay method using HPLC to test for the active ingredients phloroglucinol and trimethyl phloroglucinol. It also provides the dissolution test method using the specified medium and apparatus to ensure at least 75% of the drugs dissolve within 60 minutes.

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    spasmodic method

    Original Title

    53 spasmodic tabletstablets - (1)

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    This document provides the standard analytical procedure for testing Spasmodic Care tablets produced by Welmark Pharmaceuticals. It outlines the specifications for the core and coated tablets including description, average weight, thickness, hardness, friability, loss on drying, and disintegration time. The procedure describes the assay method using HPLC to test for the active ingredients phloroglucinol and trimethyl phloroglucinol. It also provides the dissolution test method using the specified medium and apparatus to ensure at least 75% of the drugs dissolve within 60 minutes.

    Copyright:

    © All Rights Reserved
    Download as DOCX, PDF, TXT or read online from Scribd
    Download as docx, pdf, or txt
    22 views6 pages

    53 Spasmodic Tabletstablets

    Uploaded by

    Siraj Sahib
    This document provides the standard analytical procedure for testing Spasmodic Care tablets produced by Welmark Pharmaceuticals. It outlines the specifications for the core and coated tablets including description, average weight, thickness, hardness, friability, loss on drying, and disintegration time. The procedure describes the assay method using HPLC to test for the active ingredients phloroglucinol and trimethyl phloroglucinol. It also provides the dissolution test method using the specified medium and apparatus to ensure at least 75% of the drugs dissolve within 60 minutes.

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    © All Rights Reserved
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    You are on page 1of 6

    WELMARK PHARMACEUTICALS

    Document Number
    WM/QC/SAP-FP-053
    STANDARD ANALYTICAL
    Revision Number
    0
    PROCEDURE
    Page No 1 of 6

    Innovator
    Title: SPASMODIC CARE TABLET SPECIFICATION

    Specification and testing method OF SPASMIDIC tablet

    Prepared by:....................................................

    Waheed anjum

    (Q.C Analyst)

    Checked by:...................................................

    Bilal ahmed

    (Q.C senior analyst)

    Approved by:..................................................:

    Farmanullah

    (Q.C manager)
    WELMARK PHARMACEUTICALS
    Document Number
    WM/QC/SAP-FP-053
    STANDARD ANALYTICAL
    Revision Number
    0
    PROCEDURE
    Page No 2 of 6

    Innovator
    Title: SPASMODIC CARE TABLET SPECIFICATION

    Product Specification (core)

    A)Monogram Reference No: INNOVATOR Specification

    B) Description: white color OVAL Tablet and plaine on both side

    C) Av.Weight: 340mg

    D) Thickness: 4 mm—7mm

    E) Hardness: NLT 5 Kg/cm

    F) Friability: NMT 1%

    G) Loss on Drying: NMT 5 % (GRANULE)

    H) Disintegration time: NMT 15 minutes

    I) Assay: phloroglucinol

    trimethyle phloroglucinol 90 to 110 %

    Composition:

    Each sugar coated Tablet contains:

    phloroglucinol 80mg/tablet

    trimethyle phloroglucinol 80mg/tablet


    WELMARK PHARMACEUTICALS
    Document Number
    WM/QC/SAP-FP-053
    STANDARD ANALYTICAL
    Revision Number
    0
    PROCEDURE
    Page No 3 of 6

    Innovator
    Title: SPASMODIC CARE TABLET SPECIFICATION

    Product Specification (coated) `

    a)Monogram Reference No: INNOVATOR Specification

    Description:

    white color OVAL brown color sugar coated Tablet and plaine on both side

    c) Av.Weight : 560 mg ± 3%

    d) Disintegration time: NMT 30 minutes

    e) Assay: : phloroglucinol 80mg/tablet

    trimethyle phloroglucinol 80mg/tablet

    ASSAY: Mobile phase: Buffer: ACN (1:1) Preparation of Buffer:

    Dissolve 1.33gm of potassium dihydrogen phosphate in 1000ml of water; adjust with phosphoric acid to a PH of 3.0
    Diluent: Mobile phase Standard preparation: Dissolve accurately weighed 25mg of USP Phloroglucinol
    Dihydrate & Trimethyl Phloroglucinol RS in 50ml volumetric flask and make volume with Diluent.

    Pipette 1 ml of the solution in 25 ml volumetric flask and dilute with Diluent to volume Sample solution:

    Weigh Sample equivalent to 25mg USP Phloroglucinol Dihydrate & Trimethyl Phloroglucinol RS into 50-ml
    volumetric flask, dilute with Diluent, and sonicate for about 5 minutes. Filter the sample and Pipette 1
    ml of the solution in 25 ml volumetric flask and dilute with Diluent to volume.

    Chromatographic Condition: Mode: LC Column: 25cm× 4.6mm, packing L1

    Column Temperature: Ambient


    WELMARK PHARMACEUTICALS
    Document Number
    WM/QC/SAP-FP-053
    STANDARD ANALYTICAL
    Revision Number
    0
    PROCEDURE
    Page No 4 of 6

    Innovator
    Title: SPASMODIC CARE TABLET SPECIFICATION

    Detector (UV): 265nm

    Flow Rate: 1ml/min

    Procedure: Calculate the percentage of Phloroglucinol Dihydrate & Trimethyl Phloroglucinol in the portion of
    injection taken:

    Result: (ru/rs) × (Cu/Cs) × 100

    Ru=peak area response from sample solution

    Rs= peak area response from standard solution

    Cs=concentration of standard solution

    Cu=concentration of sample solution

    DISSOLUTION: Medium: 6.8 Phosphate buffer + 0.75% Brij + 1% Tween 80 in 1 Litre of water Volume: 900 ml
    Apparatus: 02 RPM: 100 rpm Time: 60 minutes. Tolerance: NLT 75% (Q)

    Chromatographic Condition: Same as directed in Assay.

    Standard preparation: Dissolve accurately weighed 25mg of USP Phloroglucinol Dihydrate & Trimethyl
    Phloroglucinol RS in 50ml volumetric flask and make volume with Diluent. Pipette 1 ml of the solution in
    25 ml volumetric flask and dilute with Diluent to volume
    WELMARK PHARMACEUTICALS
    Document Number
    WM/QC/SAP-FP-053
    STANDARD ANALYTICAL
    Revision Number
    0
    PROCEDURE
    Page No 5 of 6

    Innovator
    Title: SPASMODIC CARE TABLET SPECIFICATION

    Procedure: Determine the amount of Phloroglucinol Dihydrate & Trimethyl Phloroglucinol dissolved. Take 20ml of
    sample and filter it .Pippet 5ml from filtrate in 25ml flask and volume with mobile phase (diluent).
    Result: (RU/RS) × (Cu/Cs) × 100

    RU=peak response of sample solution

    RS = peak response of standard solution

    Cs=concentration of standard solution

    Cu=concentration of sample solution

    :
    WELMARK PHARMACEUTICALS
    Document Number
    WM/QC/SAP-FP-053
    STANDARD ANALYTICAL
    Revision Number
    0
    PROCEDURE
    Page No 6 of 6

    Innovator
    Title: SPASMODIC CARE TABLET SPECIFICATION

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