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  • Accelerate Stability Study, Arrhenius Eqn

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    Rabwa Razak
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    The document discusses accelerated stability studies which subject drug preparations to high stresses like temperature, humidity, light, and oxygen to rapidly determine shelf life. The Arrhenius equation relates reaction rate to temperature and can be applied to predict stability at normal temperatures based on results from accelerated testing, but this method is only valid if the reaction depends mainly on temperature and has an activation energy between 10-30 kcal/mole. Specific tests are described that subject preparations to elevated temperatures, high light intensity, humidity, or oxygen to accelerate breakdown reactions.

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    The document discusses accelerated stability studies which subject drug preparations to high stresses like temperature, humidity, light, and oxygen to rapidly determine shelf life. The Arrhenius equation relates reaction rate to temperature and can be applied to predict stability at normal temperatures based on results from accelerated testing, but this method is only valid if the reaction depends mainly on temperature and has an activation energy between 10-30 kcal/mole. Specific tests are described that subject preparations to elevated temperatures, high light intensity, humidity, or oxygen to accelerate breakdown reactions.

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    117 views9 pages

    Accelerate Stability Study, Arrhenius Eqn

    Uploaded by

    Rabwa Razak
    The document discusses accelerated stability studies which subject drug preparations to high stresses like temperature, humidity, light, and oxygen to rapidly determine shelf life. The Arrhenius equation relates reaction rate to temperature and can be applied to predict stability at normal temperatures based on results from accelerated testing, but this method is only valid if the reaction depends mainly on temperature and has an activation energy between 10-30 kcal/mole. Specific tests are described that subject preparations to elevated temperatures, high light intensity, humidity, or oxygen to accelerate breakdown reactions.

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    © All Rights Reserved
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    of 9

    ACCELERATED STABILITY STUDIES

    " Stability study to predict the shelf life of


    product, by accelerating the rate of
    decomposition, preferably by increasing
    temperature of reaction.
    " These are experimental designs.
    " Preparations are subjected to high stresses
    during stability testing such as
    1. Temperature
    2. Humidity
    3. Light
    LIMITATIONS OF ACCELERATED
    STABILITY STUDIES
    " This studies are only valid when the breakdown
    depends on temperature.
    " this method is not used in case of complex reactions.
    "This method is valid only if energy of activation lies
    between 10-30Kcal/mole.
    "The products which loose their physical integrity at
    elevated temperature is not suitable for accelerated
    testing.
    "This method is not valid when order changes at
    higher temperature.
    Tests at elevated temperature:
    " Drug liquid preparation stored at 50, 60, 70,85,100 and
    121°c.
    " Also study performed at R.T. and or refrigerator temp.
    Sampling:
    First year-3month interval
    Second year- 6 month interval
    Tests at high intensity of light:
    Drug substances darken on exposing to light, can be controlled by
    using amber glass or opaque container.

    By exposing drug substance to 1oo& 121(fc)4 &2weeks to light and


    another sample examined protected from light .

    " Results found on appearance and chemical loss may be recorded.

    Comparing color or using spectroscopy for examination.

    " eg.cycloprofen becomes very yellow after five days exposing to light.
    Tests at high partial pressure of oxygen:
    Here, high oxygen tension plays important role to
    investigate stability Usually 40% of oxygen atmosphere
    allows for rapid evaluation.
    " Results were correlated with inert & without inert
    condition.
    Tests at high relative humidity:
    " Presence of moisture may cause hydrolysis and oxidation.
    These reactions may accelerated by exposing the drug to
    different relative humidities.

    " Control humidity by Lab desiccators


    Closed dessicator are placed in an oven to provide constant
    temperature.
    ARRHENIUS EQUATION
    " Itexplains the effect of temperature on the rate of reaction.
    Accordingto Arrhenius, with every 10°C rise in temperature, the
    rate of reaction increases by 2-3 times. Jemp (K)
    Rate
    constant
    k=Ae-FalRT
    Activation 8.31 x 10 kJ/K"mol
    Frequency factor energy

    " Arrhenius factor represents frequency of collisions between two


    molecules.
    Activation energy (Ea) is the amount of energy that is required for a
    reaction to get started.
    Ea
    log k - log A - 2.303RT
    What is the Arrhenius equation used for?

    The Arrhenius equation can be used to


    determine the effect of a change of
    temperature on the rate constant, and
    consequently on the rate of the reaction.
    Why Arrhenius equation is applied in
    accelerated stress stability testing?

    The Arrhenius equation is useful to estimate


    rate constant datafor temperatures not
    experimentally obtained.

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