How we can determine OOT limit in Stability
Answers were Sorted based on User's Feedback
An OOT result shall be identified by comparing the result
to a predetermined acceptable range. Any result outside
this range shall be considered as an OOT.
To identify the OOT result, there are two methods.
1. Extensive Review Range
2. ±3 Sigma Method
If number of batches are less than 50, extensive review
range method shall be followed
If number of batches are more than 50, +/- sigma method
should be followed
After completion of 50 batches/5 intervals, average and
standard deviation of the respective parameter
shall be calculated. Further ±3 sigma values shall be
defined as below
+3 sigma = Average + (3 x Standard deviation)
-3 sigma = Average - (3 x Standard deviation)
Ex: Assay : 98.00% to 101.00%
Average of 50 batches : 99.81%
Standard deviation : 0.20
+3 sigma = 99.81 + (3 x 0.20) = 100.41%
-3 sigma = 99.81 – (3 x 0.20) = 99.21%
OOT range : ‘98.00 to 99.20%’ and ‘100.42%
to 101.00%
Is This Answer Correct ? | 20 Yes | 6 No |
Answer / shailesh dudhat
How many Batches Required for OOT Establishment
Is This Answer Correct ? | 1 Yes | 0 No |
Why pH lies between 0 to 14 only
4 Answers PI Industries, Unimark Remedies,
what is the definition of Precision.
For Dissolution test why we are Performing 6 Bowls why not more.any were mentioned or in what basis we are performing? --------Veerabhadrarao.M
2 Answers Lee Pharma, Micro Labs,
which one is better separation in high pressure liquide chromatogram orlowpressure chromato gram in hplc
What is the lab normality??
how to qualify the impurity?
In lcms analysis some times we get sodium and potassium adducts. if the compound is havine sodium ions how can we confirm wether sodium is from sample or it is a adduct?
2 Answers Teva Pharmaceuticals,
difference between pH & pOH ?
why water content test performed
On which pharmacopoeia basis we can calibrate instruments like HPLC,GC,UV,DISSO,IR etc...
9 Answers Cipla, Laurus, Micro Labs,
Why only 1.2 million lux hours require in photostability study?
on what basis SOP's can be changed? IF mobile phase ratio is 70:30 to how much % can we change the ratio in HPLC process