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79] reported on the photo-mediated auto-oxidation of dithiophene, an anti-cancer drug. Dithiophene photodegrades via oxidation of the alcohol function to the 2-aldehyde and subsequently the 2-carboxylic acid degradants. Interestingly, under anaerobic conditions the degradation was more complex, but one of the photodegradants was the same: the 2-aldehyde. It was speculated that the degradation pathway under these conditions was primarily via a disproportionation mechanism. After clinical treatment with topical products photodecomposition may occur on the skin surface, or indeed during the transit through the dermis, and may subsequently cause adverse skin reactions [80, 81].

Fortunately, this is also a prerequisite from the perspective of dissolution and bioavailability, as owing to its hydrophobic nature, magnesium stearate may retard the dissolution of a drug from a solid oral dosage form [46]. It is likely that other low melting lubricants will behave in a similar manner. Ibuprofen is known to form eutectics with excipients, resulting in loss of potency due to sublimation. Gordon et al. 5). 6 Processing as a source of moisture Crowley and Martini [48] reported on several studies evaluating the impact of unit process operations on hydrates.

19] reported that the degradation pathway of prevastatin sodium was directly linked to the micro-pH environment within the formulation. 5), the statin formed two degradation products, a cyclic lactone and an internal hydroxyl rearrangement product. 9 with the incorporation of magnesium oxide into the blend, the only degradation mechanism involved the formation of the cleavage product, 2-methylpropanoic acid. This latter approach of increasing the 28 ANALYSIS OF DRUG IMPURITIES formulation pH was adopted to facilitate the long-term stabilisation of the drug product [36].

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