Analysis of Drug Impurities (Sheffield Analytical Chemistry by Richard J. Smith, Michael L. Webb

By Richard J. Smith, Michael L. Webb

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By Richard J. Smith, Michael L. Webb

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99] determined the theoretical rate of water permeation through a standard 60-cc bottle when stored at 40ЊC/75% RH. This equated to an uptake of 1 mg of water per day. They commented that even if the product had been packed under low water vapour conditions the relative humidity conditions within the container would be equate to 50% RH within 1 day. 8) for some common packaging materials were reported by Waterman et al. [99]. 0005 Source: Derived from [99]. Note: PVC, Polyvinylchloride; PET, polyethyleneteraphthalate; HDPE, high density polyethylene.

Aman and Thoma [38] showed that the photostability of molsidomine tablets manufactured using differing lubricants with different acidities or basicities was essentially the same. They utilised stearic acid, glycerylpalmitostearate and magnesium stearate to represent acidic, neutral or basic lubricants. In all cases, the photodegradation was similar, and marked, with drug losses between 35% and 40% after 12 h irradiation. Despite being marketed for over five decades, levothyroxine tablets, 50 μg, continue to have numerous product recalls due to degradation, and resultant failure to meet approved product specifications [39].

This allowed the evaluation of the role of the chemical nature of the excipient, the ratio of the drug–excipient blend, pH of the drug–excipient blend, role of moisture in the drug–excipient blend, as well as the more classically important roles of temperature, light and humidity of the external environment. The authors disagreed with Monkhouse and Maderich [14] about the utility of drug–excipient testing. They concluded that on the basis of case histories that the stability of drug products could be optimised by selection of excipients according to this approach, and that late-stage development surprises were less likely if this model was adopted.

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