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By Pittman J., Huang E., Nevis J.

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In this chapter our efforts are directed to a discussion of accelerated stability testing in terms of application of the Arrhenius equation for the relationship between degradation and temperature. In the next section we describe briefly some deterministic chemical kinetic models. The Arrhenius equation is also described in this section. 2. 3 covers determination of the order of a reaction by selection of adequate models. Also included in this section are issues that often occur in the design of accelerated stability testing.

2 Content Uniformity Testing For the determination of dosage uniformity by assay of individual units, the USP-NF requires that the following be done. First, assay 10 units individually, as described in the assay in the individual monograph, unless specified otherwise in the test for content uniformity. Where a special procedure is specified in the test for content uniformity in the individual monograph, the results should be adjusted. Note that the requirements as described for weight variation apply only if the average of the limits specified in the potency definition in the individual monograph is 100% or less.

3 Stability Testing 17 of the active ingredient in each of the 10 units, assuming homogenous distribution of the active ingredient. 0%. 0%, or if both conditions prevail, test 20 additional units. 8%. 2 Content Uniformity Testing For the determination of dosage uniformity by assay of individual units, the USP-NF requires that the following be done. First, assay 10 units individually, as described in the assay in the individual monograph, unless specified otherwise in the test for content uniformity.

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Bayesian analysis of binary prediction tree models for retrospectively sampled outcomes by Pittman J., Huang E., Nevis J.


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