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How to decide restandardisation due or retest or expiry of
Volumetric solutions prepared in wet chemistry lab?
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It is pre stability study of volumetric solutions. using a
standardisation.
For Eg: If you take 0.1 M Sulphuric acid, It is
standardised with sodium carbonate, we test it for 15 days
daily. the obtained molarity shuld be varied not more than
10 %. that is 0.09 to 0.11. then the expiry can be given
for 15 days.
Restandardisation period and retest period is same incase
of volumetric solutions.
Restandardisation date is decided based on the changes in
normality on testing everyday during pre stability studies.
The variation is little bit for 5 days. then we can set
restandardisation period for every 5 days.
| Is This Answer Correct ? | 32 Yes | 7 No |
Answer / alpesh patel
In short, we can decide the restandardisation period or
shelf life of the Volumetric Solutions based on trend
data/analysis.
| Is This Answer Correct ? | 14 Yes | 6 No |
Answer / siva
To establish retest or expiry date of volumetric solutions
we have to conduct stability study i.e. day 1 to day 30
through a protocol. based on results we can establish
retest date of volumetric solutions.
Acceptance criteria : At fixed intervals check
predetermined specifications i.e. Apperance and Strenghs. %
RSD for particular intervals shall not more than 1%.
| Is This Answer Correct ? | 10 Yes | 3 No |
Answer / jayesh patel
Here is your reply.
Case 1, expiry of volumetric solution ]: Stability study of
volumetric study needs to be conducted on the basis of
predefined protocol. We can use volumetric solution till it
differ from the 10% predescribed value. i.e in case if
Normality of 1.0 N NaoH ( predescribed , we can use it up to
10% i.e till we get normality of NaOH is 0.9000.
Case 2, re standardization of volumetric solution ]: Again
stability study is required to assess expiry. Standardize it
on the day of preparation or next day, consider this is
first standardization. Every day do standardization till you
differ normality value by 2%. ie. 0.98.
| Is This Answer Correct ? | 2 Yes | 2 No |
Answer / yugandhar
restandardisation period is based on the holding time study analysis (1st,3rd,5th 7th 9th 12th 15th 22th 30th 45th) if 45thday is failed within limit we considerd 30th day
| Is This Answer Correct ? | 0 Yes | 0 No |
Answer / pankaj punjabi
To establish retest or expiry date of volumetric solutions
we have to conduct validation of stability study i.e.
initial (day-1) ,7,15,30 days of intervals through a
protocol. based on results we can establish retest date of
volumetric solutions.
Suppose we wont to decide validity up to 30 days,we need to
conduct stability up to 45 days,if it's stable up to 45
days (physical apperance and strength) then we will give up
to 30 days validity.
Acceptance criteria : As per EP 6.0, RSD of three replicate
analysis is NMT 0.02%
| Is This Answer Correct ? | 3 Yes | 8 No |
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