PROCEDURE :
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Solution
prepared for chemical analysis is not stable for longer period. Incorrect
strength/ concentration can affect the result of analysed products.
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Shelf
life of solution depends on nature of chemical, solvent and temperature of
storage.
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Therefore
it is necessary to validate the stability period individually.
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Prepare
and standardise the volumetric solutions
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Ascertain
shelf life of volumetric solution by visual inspection for precipitation and
turbidity.
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Record
the observation daily
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Ascertain
shelf life of the volumetric solution by standardisation of the solution 6
times at an interval of one week starting from the date of preparation.
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Frequency
of Standardisation:
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First
Standardisation
: Date of
Preparation
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Second
Standardisation : On 07
day + 1 day
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Third
Standardisation
: On 14 day + 1 day.
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Fourth
Standardisation
: On 21 day + 1 day.
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Fifth
Standardisation
: On 28 day + 1 day.
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Sixth
Standardisation
: On 35 day +
1 day.
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Perform
the standardisation twice for each time and take a mean.
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Record
the observation
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Deviation
for standardisation values shall not be more than 1.0 % from the initial
result.
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Assign
shelf life after completion of validation.
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Saturday, 7 October 2017
Validation of Volumetric solutions
Posted by mypharmasolution.blogspot.com on October 07, 2017