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  • Vasa - Croscarmellose Sodium - TDS

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    NUTRA STEVIA EIRL
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    The document provides a finished product specification for croscarmellose sodium. It lists 17 tests for properties such as description, solubility, identification, pH, loss on drying, sulphated ash, degree of substitution, heavy metals, microbial contamination, bulk density, and sieve analysis. The specification references compendial standards from the Indian Pharmacopoeia, British Pharmacopoeia, European Pharmacopoeia, and United States Pharmacopeia. It was prepared by the executive of quality assurance, reviewed by the quality control manager, and approved by the quality assurance manager of Vasa Pharmachem Pvt. Ltd.

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    VASA - CROSCARMELLOSE SODIUM - TDS

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    The document provides a finished product specification for croscarmellose sodium. It lists 17 tests for properties such as description, solubility, identification, pH, loss on drying, sulphated ash, degree of substitution, heavy metals, microbial contamination, bulk density, and sieve analysis. The specification references compendial standards from the Indian Pharmacopoeia, British Pharmacopoeia, European Pharmacopoeia, and United States Pharmacopeia. It was prepared by the executive of quality assurance, reviewed by the quality control manager, and approved by the quality assurance manager of Vasa Pharmachem Pvt. Ltd.

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    © All Rights Reserved
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    103 views2 pages

    Vasa - Croscarmellose Sodium - TDS

    Uploaded by

    NUTRA STEVIA EIRL
    The document provides a finished product specification for croscarmellose sodium. It lists 17 tests for properties such as description, solubility, identification, pH, loss on drying, sulphated ash, degree of substitution, heavy metals, microbial contamination, bulk density, and sieve analysis. The specification references compendial standards from the Indian Pharmacopoeia, British Pharmacopoeia, European Pharmacopoeia, and United States Pharmacopeia. It was prepared by the executive of quality assurance, reviewed by the quality control manager, and approved by the quality assurance manager of Vasa Pharmachem Pvt. Ltd.

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    of 2

    VASA PHARMACHEM PVT. LTD.

    11, GIDC, BEHRAMPURA, AHMEDABAD – 380022

    FINISHED PRODUCT SPECIFICATION

    Name of Finished Product : CROSCARMELLOSE SODIUM IP/BP/EP/USP

    Product Code : CSS3-R Page No. : 1 of 2

    Specification No. : VBFS232CSS3-R/1 Reference : IP/BP/Ph.Eur./USP-NF/IH

    Effective Date : 01/03/2021 Supersede No. : VBFS232CSS3-R/0

    Review Period : 3 YEARS OR ANY CHANGE IN PHARMACOPOEIA

    Sr. Test Standard Reference


    No.
    1. Description A white or greyish-white powder. IP/USP
    White or greyish-white, hygroscopic powder. BP/EP
    2. Solubility Slightly soluble in water; insoluble in ethanol, ether and in IP
    other organic solvents.
    Practically insoluble in acetone, in anhydrous ethanol and in BP/EP/USP
    toluene.
    3. Identification A) The substance to be examined absorbs the methylene IP/BP/EP/USP
    blue and settles as a blue, fibrous mass.
    B) A reddish-violet colour develops at the interface. IP/BP/EP/USP
    C) The solution gives reaction (a) of sodium. IP/BP/EP
    D) Sodium compound shall impart an intense Yellow colour USP
    to a non-luminous flame.
    4. pH 5.0 to 7.0 (Mix 1 g with 100 ml of water for 5 min). IP/BP/EP/USP

    5. Sodium chloride & Not more than 0.5% w/w calculated on dried substance. IP/BP/EP/USP
    Sodium glycollate
    6. Loss on drying Not more than 10.0% w/w at 105°C for 6 h. IP/BP/EP/USP

    7. Sulphated ash 14.0% w/w to 28.0% w/w calculated on the dried basis. IP/BP/EP

    8. Residue on 14.0% w/w to 28.0% w/w calculated on the dried basis. USP
    Ignition
    9. Degree of 0.60 to 0.85 calculated on the dried basis. IP/BP/EP/USP
    substitution
    10. Water soluble Not more than 10.0% w/w. IP/BP/EP/USP
    substances
    11. Settling volume 10.0 ml and 30.0 ml. IP/BP/EP/USP

    Prepared by Reviewed by Approved by

    Signature

    Date 25/02/2021 26/02/2021 27/02/2021

    Name JALPA VANSJALIA JALDEEP PATEL HARNISH PARIKH


    EXECUTIVE - QA MANAGER - QC MANAGER - QA
    VASA PHARMACHEM PVT. LTD.
    11, GIDC, BEHRAMPURA, AHMEDABAD – 380022

    FINISHED PRODUCT SPECIFICATION

    Name of Finished Product : CROSCARMELLOSE SODIUM IP/BP/EP/USP

    Product Code : CSS3-R Page No. : 2 of 2

    Specification No. : VBFS232CSS3-R/1 Reference : IP/BP/Ph.Eur./USP-NF/IH

    Effective Date : 01/03/2021 Supersede No. : VBFS232CSS3-R/0

    Review Period : 3 YEARS OR ANY CHANGE IN PHARMACOPOEIA

    Sr. Test Standard Reference


    No.
    12. Heavy metals Not more than 20 ppm. IP

    13. Residual solvents Methanol : Not more than 3000 ppm USP

    14. Microbial Contamination a) Aerobic microbial count: Not more than 1000 cfu/g. IP/BP/EP/USP
    b) Moulds & yeasts count : Not more than 100 cfu/g.
    c) Escherichia coli : Should be absent.
    15. Bulk Density 0.35 g/ml to 0.55 g/ml IH

    16. Tap Density 0.55 g/ml to 0.75 g/ml IH

    17. Sieve Analysis


    (-) 200# 100.00% w/w IH

    Prepared by Reviewed by Approved by

    Signature

    Date 25/02/2021 26/02/2021 27/02/2021

    Name JALPA VANSJALIA JALDEEP PATEL HARNISH PARIKH


    EXECUTIVE - QA MANAGER - QC MANAGER - QA

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