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    Spec Rodano

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    Danesh Az
    This certificate provides the results of standard analysis tests conducted on a product called COLESTEROLO RPH. The tests evaluated the description, identification, acidity, alcohol solubility, organic volatile impurities, melting point, specific optical rotation, loss on drying, sulphated ash, and assay of cholesterol and total sterols. The product met all specifications. A note indicates it should not be used as an active pharmaceutical ingredient.

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    Spec Rodano

    Uploaded by

    Danesh Az
    5 views1 page
    This certificate provides the results of standard analysis tests conducted on a product called COLESTEROLO RPH. The tests evaluated the description, identification, acidity, alcohol solubility, organic volatile impurities, melting point, specific optical rotation, loss on drying, sulphated ash, and assay of cholesterol and total sterols. The product met all specifications. A note indicates it should not be used as an active pharmaceutical ingredient.

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    335530_SPEC_RODANO

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    This certificate provides the results of standard analysis tests conducted on a product called COLESTEROLO RPH. The tests evaluated the description, identification, acidity, alcohol solubility, organic volatile impurities, melting point, specific optical rotation, loss on drying, sulphated ash, and assay of cholesterol and total sterols. The product met all specifications. A note indicates it should not be used as an active pharmaceutical ingredient.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Flag for inappropriate content
    Download as pdf or txt
    5 views1 page

    Spec Rodano

    Uploaded by

    Danesh Az
    This certificate provides the results of standard analysis tests conducted on a product called COLESTEROLO RPH. The tests evaluated the description, identification, acidity, alcohol solubility, organic volatile impurities, melting point, specific optical rotation, loss on drying, sulphated ash, and assay of cholesterol and total sterols. The product met all specifications. A note indicates it should not be used as an active pharmaceutical ingredient.

    Copyright:

    © All Rights Reserved
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    of 1

    Carlo Erba Reagents S.r.l. Carlo Erba Reagents S.A.S. Z.

    I DE VALDONNE - BP 4
    Via R. Merendi, 22 Parc d'Activités des Portes 13124 PEYPIN
    20010 Cornaredo (Mi) Chausée du Vexin - BP 616 Tél.:04.42.32.41.41
    Tel. 02 93 991 90 Fax 02 93 991 27106 Val de Reuil Cedex Fax 04.42.72.41.62
    001 Tél.:02.32.09.20.00
    www.carloerbareagents.com

    ISO 9001: 2008

    Standard Analysis Certificate


    PRODUCT :COLESTEROLO RPH (BP-FU-Ph.Eur.-NF)
    CODE :335530
    METHOD :7335

    TEST U.M. SPECIFICATION

    Description - Yellowish powder


    Identification - Positive
    Acidity Ph.Eur. Conform
    Alcohol solubility Ph.Eur. Conform
    Organic volatile impurities NF Conform
    Melting point °C 147 ÷ 150
    Specific optical rotation ° -34 ÷ -38
    (C=2 Dioxane) -
    Loss on drying % <=0.3
    Sulphated ash % <=0.1
    Assay (cholesterol) % ss >=95.0
    Assay (total sterols) % ss 97.0 ÷ 103.0

    Don't use as API (Active Pharmaceutical Ingredient)

    Date
    :18/01/2014
    QUALITY CONTROL RESPONSIBLE
    B. COULANGE (VDR)

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