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U.L.<br />
Potency<br />
L.L.<br />
Calculation of minimum release<br />
LRL<br />
} Error term<br />
potency (LRL)<br />
•Goal of calculation:<br />
•A lot with a potency test revealing a mean<br />
potency at the minimum release specification<br />
LRL has a 95% chance of retaining a mean<br />
potency at or above L.L. at the time of expiry<br />
Time<br />
Expiry<br />
} Expected stability loss
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