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    British Pharmacopoeia Chemical Reference Substance Information Leaflet

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    Marcelo Mendez
    This document provides information about a batch of Prednisolone Sodium Phosphate chemical reference substance from the British Pharmacopoeia. It specifies the declared content, intended use for British Pharmacopoeia monographs, and additional corrections needed for certain assays involving prednisolone or its derivatives. The corrections account for related substances detected in this batch by liquid chromatography. When using BPCRS for quantitative purposes, analysts must verify that the batch number matches what is listed in this information leaflet.

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

    British Pharmacopoeia Chemical Reference Substance Information Leaflet

    Uploaded by

    Marcelo Mendez
    65 views2 pages
    This document provides information about a batch of Prednisolone Sodium Phosphate chemical reference substance from the British Pharmacopoeia. It specifies the declared content, intended use for British Pharmacopoeia monographs, and additional corrections needed for certain assays involving prednisolone or its derivatives. The corrections account for related substances detected in this batch by liquid chromatography. When using BPCRS for quantitative purposes, analysts must verify that the batch number matches what is listed in this information leaflet.

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    prednisolone SF

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    This document provides information about a batch of Prednisolone Sodium Phosphate chemical reference substance from the British Pharmacopoeia. It specifies the declared content, intended use for British Pharmacopoeia monographs, and additional corrections needed for certain assays involving prednisolone or its derivatives. The corrections account for related substances detected in this batch by liquid chromatography. When using BPCRS for quantitative purposes, analysts must verify that the batch number matches what is listed in this information leaflet.

    Copyright:

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

    British Pharmacopoeia Chemical Reference Substance Information Leaflet

    Uploaded by

    Marcelo Mendez
    This document provides information about a batch of Prednisolone Sodium Phosphate chemical reference substance from the British Pharmacopoeia. It specifies the declared content, intended use for British Pharmacopoeia monographs, and additional corrections needed for certain assays involving prednisolone or its derivatives. The corrections account for related substances detected in this batch by liquid chromatography. When using BPCRS for quantitative purposes, analysts must verify that the batch number matches what is listed in this information leaflet.

    Copyright:

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

    British Pharmacopoeia Commission Secretariat

    MHRA, 10 South Colonnade, Canary Wharf


    London, E14 4PU
    United Kingdom

    British Pharmacopoeia Commission Laboratory


    Queen’s Road
    Teddington, TW11 0LY
    United Kingdom

    www.pharmacopoeia.com

    BRITISH PHARMACOPOEIA CHEMICAL REFERENCE SUBSTANCE


    INFORMATION LEAFLET

    PREDNISOLONE SODIUM PHOSPHATE


    CATALOGUE NUMBER 292
    CURRENT BATCH: 3831

    Declared Content
    Calculated by user.

    Use
    This British Pharmacopoeia Chemical Reference Substance (BPCRS) is to be used as directed in the
    monograph(s) of the British Pharmacopoeia and is not intended for any other purpose.

    Reference Chromatogram(s)
    None given.

    Additional Information
    The following correction is required for Prednisolone Enema (assay):

    Multiply the calculated content of C21H28O5 by 0.988.

    The following correction is required for Prednisolone Sodium Phosphate Ear Drops (assay) and
    Prednisolone Sodium Phosphate Eye Drops (assay):

    Multiply the calculated content of C21H27Na2O8P by 0.988.

    Version: 02 Last Revised: 24/01/2019 Page 1 of 2


    British Pharmacopoeia Commission Secretariat
    MHRA, 10 South Colonnade, Canary Wharf
    London, E14 4PU
    United Kingdom

    British Pharmacopoeia Commission Laboratory


    Queen’s Road
    Teddington, TW11 0LY
    United Kingdom

    www.pharmacopoeia.com
    The correction takes into account the value of related substances detected by liquid chromatography in
    the current batch of prednisolone sodium phosphate BPCRS.

    When a British Pharmacopoeia Chemical Reference Substance (BPCRS) is directed to be used in an


    Assay or quantitative determination described in a monograph of the British Pharmacopoeia or the
    British Pharmacopoeia (Veterinary) the following statements apply.

    Where a “declared content” is required the content stated on this leaflet is of the current batch of the
    BPCRS and is quoted on an ‘as is’ basis. This figure is to be used in calculating the results of the
    assay.

    It is the responsibility of the analyst using any BPCRS for quantitative purposes to assure himself or
    herself that the batch number on the label corresponds with the batch number given on this leaflet.

    For additional information on BPCRS please visit the British Pharmacopoeia website.
    https://www.pharmacopoeia.com

    Version: 02 Last Revised: 24/01/2019 Page 2 of 2

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