Shelf life average content

CuDAL Approach. The CuDAL approach is specifically written for tablets or capsules. This approach is recommended in the PDA paper [1] for final product testing. For content uniformity, when the potency limits are not symmetrical about 100% of label claim, the USP 25 content uniformity test allows the individual results to be expressed as either a percentage of the label claim, the found mean, or the average of the upper and lower potency specifications, depending on the value of the sample mean. Acceptance limits have not been constructed for the more complicated situation in which the potency shelf life limits are not symmetric about 100%. One approach to this problem is to evaluate the content uniformity results twice. First express the sample mean as a percentage of label claim and then express the mean as a percentage of the average of the potency specifications. To pass the acceptance limits, both means must meet the acceptance criteria. To use the dissolution acceptance limit tables, the value of Q is required. 

A better estimate would be obtained by dividing the time up into shorter intervals, and averaging Ap across each of those shorter intervals, instead of over the whole shelf life. For example, we could use two intervals, 8% to 22.9% RFI and 22.9% to 43%, giving an average RFIj as 15.45% RFI and 33.0% RFI in the two intervals. The cracker moisture content at 22.9% RFI is read from the graph as 3.9%. Then the calculation for the two steps is as follows ... 

The ambient temperature stability (shelf life) of poly(caprolactone) is strongly affected by its carboxyl content (16). Upon storage at ambient temperature the polymers display a gradual decrease in molecular weight with time which seems to proceed autocatalytically and is related to a random hydrolytic reaction. The average decrease in intrinsic viscosity observed for several samples after 12 and 24 months of storage was 10 and 25%, respectively. 

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