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    Definition "Impurity": DR .Krishna Sarma Pathy, Prof .P.Atchutaramaiah

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    Drkrishnasarma pathy
    The document defines impurities and discusses their origin and regulation. Impurities are more likely to form during synthesis of active pharmaceutical ingredients rather than in final drug products. Guidelines from ICH cover impurity identification and documentation for drug substances and products. Impurity synthesis involves detecting impurities, understanding how they form, synthesizing them, and determining their structure using various analytical techniques. Purity determination of impurities is also important for accurate quantification in APIs and drug products.

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    Definition "Impurity": DR .Krishna Sarma Pathy, Prof .P.Atchutaramaiah

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    Drkrishnasarma pathy
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    The document defines impurities and discusses their origin and regulation. Impurities are more likely to form during synthesis of active pharmaceutical ingredients rather than in final drug products. Guidelines from ICH cover impurity identification and documentation for drug substances and products. Impurity synthesis involves detecting impurities, understanding how they form, synthesizing them, and determining their structure using various analytical techniques. Purity determination of impurities is also important for accurate quantification in APIs and drug products.

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    DEFINITION “IMPURITY”

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    The document defines impurities and discusses their origin and regulation. Impurities are more likely to form during synthesis of active pharmaceutical ingredients rather than in final drug products. Guidelines from ICH cover impurity identification and documentation for drug substances and products. Impurity synthesis involves detecting impurities, understanding how they form, synthesizing them, and determining their structure using various analytical techniques. Purity determination of impurities is also important for accurate quantification in APIs and drug products.

    Copyright:

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    Download as PDF, TXT or read online from Scribd
    Flag for inappropriate content
    Download as pdf or txt
    56 views19 pages

    Definition "Impurity": DR .Krishna Sarma Pathy, Prof .P.Atchutaramaiah

    Uploaded by

    Drkrishnasarma pathy
    The document defines impurities and discusses their origin and regulation. Impurities are more likely to form during synthesis of active pharmaceutical ingredients rather than in final drug products. Guidelines from ICH cover impurity identification and documentation for drug substances and products. Impurity synthesis involves detecting impurities, understanding how they form, synthesizing them, and determining their structure using various analytical techniques. Purity determination of impurities is also important for accurate quantification in APIs and drug products.

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    DEFINITION “IMPURITY” 

    Dr .Krishna sarma pathy,Prof .P.Atchutaramaiah 
    drkrishnasarmapathy@yahoo.com ANDHRAUNIVERSITY ,VISAKHAPATNAM

    ABSTRACT:

    Impurities are normally generated during the formation of Active Pharmaceutical


    Ingredients and their intermediates. Chances of their generation during Drug Products
    formation are less as formulation is a physical blending process. Care is taken that these
    excipients do not react with each other to produce the degradants. They may consist of
    organic and inorganic, and define levels at which impurities/degradants should be
    identified.

    ICH Q3A covers drug substances and Q3B covers drug products. These guidelines define
    what investigations and documentation should be made in investigating impurities and
    degradation products seen in stability studies at recommended storage conditions. Based
    on the data generated their specification can be arrived at. Depending on their amount the
    qualification, if required is carried out.

    Impurity synthesis involves three steps: Detection, Modes of Formation, Synthesis and
    Structure elucidation by using various techniques. Determination of Purity of Impurity is
    mandatory otherwise its quantification in the API and Drug products can be challenged.
    Dr.krishnasarmapathy, definition "impurity"

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