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Overaging effect

Swiss case The following means were found 20.32, 20.43, 20.34, 20.60, 20.35, 20.36, 20.45, 20.40, 20.30, and 20.31. The number of tubes with fill weights below the -5% limit was 4, 1, 0, 0, 4, 1, 3, 3, 3, and 3, for a total of 22, and none below the -12.5% one. Twenty-two tubes out of 500 tested correspond to 4.4%. Since the limit is 5% failures, or 2.5 per 50, fully six out of 10IPC inspection runs at u = 50 each did not comply. At a total batch size of 3000 units, eventually 1 /6 of all packages were tested. Evidently, unless the filling overage is further increased, a sampling rate of well above 10% is necessary to exclude these stochastic effects, and so the 10 inspections were combined into one test of n = 500. [Pg.242]

The purpose of stability testing is to assess the effects of temperature, humidity, light, and other environmental factors on the quality of a drug substance or product. The data produced are used to establish storage conditions, retest periods, shelf loss, and to justify overages included in products for stability reasons. The most useful equation relating temperature and reaction rate is the Arrhenius equation. This equation (27) may be integrated and rewritten as Eqs. (31) and (32). [Pg.158]

If vitamins are added to a product to make a nutritional claim, it is critical that shelf-life studies are undertaken to prove that the overages added are sufficient to ensure that the label claims can be met at the end of product shelf life. This is important as none of the vitamins are fully stable in a soft drink environment and some, for instance vitamin C, are very quickly lost in the presence of oxygen. The addition of the fat-soluble vitamins to a soft drink also offers a formulation challenge to ensure that they are fully dispersed and that there are no problems with neck ringing during storage. Trace metals, particularly the transition elements, can also have a deleterious effect on vitamin shelf life, and sometimes metal scavengers, such as EDTA or phosphate salts, are added to improve the shelf life. [Pg.267]

The number of doses will normally depend on the vaccine and the proposed clinical dosing schedule. In most cases, a N + 1 approach is used (one dose more than the clinical schedule22), which should provide an overage in the safety margin. However, in certain cases, only a single dose is needed. For example, for a Japanese encephalitis vaccine, to assess the effect of a viremia, only one dose was given to support a clinical regimen of one dose the viremia was only evident after one dose (unpublished data). [Pg.347]

Silver has a significant effect in delaying the discontinuous precipitation reaction as well as the overageing of calcium precipitates [90]. Silver also increases the corrosion resistance of lead-calcium tin alloys — particularly under conditions that simulate end-of-discharge (high pH) conditions — and improves the cycle-life and capacity of VRLA batteries. Silver decreases the thickness of the PbO layer but produces a harder, more compact, corrosion layer than tin. Silver does not, however, increase the conductivity of the corrosion layer. [Pg.30]

CensMer the overage sub-humon living in the anonymity of o city. He ll never be known for anything positive. But such o wimp wonts to feel important, even in o negative way. He wonts to be on effect, even if he s the only one who knows about it. [Pg.40]

Temperatures as low as the aging temperature will remove most of the Bauschinger effect in solution-treated titanivim alloys. Heating or plastic deformation at temperatures above the normal aging temperature for solution-treated Ti-6A1-4V may eliminate the Bauschinger effect, but may, depending on temperature and time, cause overaging. [Pg.711]

For 7XXX series alloys, the beneficial effects that can result from overaging are strongly influenced by the presence of copper. [Pg.299]


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