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    Assay by Titrimetry:: What Are These Known Impurity & Unknown Impurity ?

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    thomas_v501925
    This document discusses different methods for calculating assay values and related substances for chemical samples. It provides formulas for determining assay by titrimetry, HPLC, and GC. For HPLC, it explains how to calculate assay content, related substances for known and unknown impurities, and defines relative retention time. For GC, a formula is given for calculating residual solvents. Key terms like molarity, weight, area, and response factor are also defined in the context of these analytical methods and calculations.

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    Assay by Titrimetry:: What Are These Known Impurity & Unknown Impurity ?

    Uploaded by

    thomas_v501925
    57 views3 pages
    This document discusses different methods for calculating assay values and related substances for chemical samples. It provides formulas for determining assay by titrimetry, HPLC, and GC. For HPLC, it explains how to calculate assay content, related substances for known and unknown impurities, and defines relative retention time. For GC, a formula is given for calculating residual solvents. Key terms like molarity, weight, area, and response factor are also defined in the context of these analytical methods and calculations.

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    Analytical

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    Analytical

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    This document discusses different methods for calculating assay values and related substances for chemical samples. It provides formulas for determining assay by titrimetry, HPLC, and GC. For HPLC, it explains how to calculate assay content, related substances for known and unknown impurities, and defines relative retention time. For GC, a formula is given for calculating residual solvents. Key terms like molarity, weight, area, and response factor are also defined in the context of these analytical methods and calculations.

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    © All Rights Reserved
    Download as DOCX, PDF, TXT or read online from Scribd
    Download as docx, pdf, or txt
    57 views3 pages

    Assay by Titrimetry:: What Are These Known Impurity & Unknown Impurity ?

    Uploaded by

    thomas_v501925
    This document discusses different methods for calculating assay values and related substances for chemical samples. It provides formulas for determining assay by titrimetry, HPLC, and GC. For HPLC, it explains how to calculate assay content, related substances for known and unknown impurities, and defines relative retention time. For GC, a formula is given for calculating residual solvents. Key terms like molarity, weight, area, and response factor are also defined in the context of these analytical methods and calculations.

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    Assay by Titrimetry :

    Assay is nothing but content of the desired material in the given sample, assay can be calculated
    on two basis, by

    1) Titrations and
    2) HPLC / GC

    Assay by Titrations = [Titrate value of (sample - blank) x M x F x 100 x 100 ] / [Ws x (100- LOD)]

    Where,
    M  - Molarity of Volumetric Solution,
    Ws - Weight of solution,
    F  - Factor for drug substance,
    LOD - Loss On Drying.

    Assay content by HPLC :


    Assay  =  [ At x Ws x P x (100 - LOD of std ) ] / [ As x Wt x ( 100 - LOD of sample) ],

    Where,
    At  -  Area of the sample,
    As - Area of the Standard,
    Ws - Weight of the standard,
    Wt - Weight of the Sample,
    P - Potency or Assay of standard.

    RS[Related Substances] by HPLC :


    There will be mostly two formulae which will be helpful for calculating RS by HPLC,

    1) Calculating known impurity Level,


    2) Calculating unknown impurity level.

    Calculating known impurity level :

    % of known impurity  =  ( Ri / Rs ) x 100 x RF

    % of unknown impurity = ( Ri / Rs ) x 100

    May be right now, you may get a doubt 

    What are these known impurity & unknown impurity ?


     Known Impurity : The impurity which will be detected at a known RRT is called known
    Impurity, 
    Unknown Impurity : The impurity which will be detected at a unknown RRT is called
    Unknown impurity.
    Another Query you may get here, & i.e., 

    What is RRT ?
    RRT stands for Relative Retention Time
    Usually our sample for which HPLC need to be performed is pressurized into a column and while
    this process under progress, some peaks will be observed at some particular times based on the
    Standard solution,
    and the time interval denotes the Retention time, the ratio of the sample peak Retention time to
    the Standard peak Retention time is nothing but our Relative Retention Time.

    Ri - Area of each impurity Peak in the chromatogram of the sample solution,

    Rs - Sum of areas of Main drug and all impurity Peaks in the chromatogram of the sample
    solution,

    RF - Response Factor.

    Total Impurities = Sum of known impurities + Sum of unknown impurities.


    You may also like:

    How to perform Material balance ? 

    Calculate LMTD correction factor

    RS[Residual Solvents] by GC :
    This is most used term while describing a dry product Purity & LOD, Usually RS by GC will give a
    clear idea about how much of solvent is being washed away from the material during a filtration,
    also it characterizes the drying efficiency, 

    RS by GC can be calculated as

     = (At/As) x (Vol. of solvent taken x Density/10ml) x (0.1/10ml) x (Dilution of sample/Weight of


    sample) x (10^6)

    At= Area of the solvent in the sample - Blank


    As= Area of the solvents in the standard -blank 

    Note: Volume of the solvents taken should be mentioned in microliters 

    As we are multiplying with 10 power 6 we can get the results in PPM

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