Product stability assessment, active

Concern about the quality of botanical products poses another regulatory challenge. Most botanical products are complex and variable mixtures of constituents too numerous to characterize individually. For many preparations, active ingredients have not been identified and it is thus difficult to quantify strength or potency of the botanical product. Because of the biological nature of botanical products, the assessment of their impurity and stability is often more problematic than that of nonbotanical pure drugs. 

The above studies have been conducted with a beam instrument, where the ion-molecule adduct Fe(alkyne) is first isolated before its spontaneous or collisionally activated dissociation products are assessed. It has been shown, however, that reaction of bare Fe" with alkynes in an ICR mass spectrometer leads to similar products now, the intermediate Fe(alkyne) adduct may not be observed due to the absence of stabilizing collisions in the ICR environment . 

These authors also report a comparison of the efficacy of wet cells compared with heat-dried cells and with Pichia extracts. This appears to show the best result with the extracts, but it is difficult to assess the meaning of this study. The outcome is reported in terms of percentage yield of the final product, and it is impossible to judge whether what is being observed reflects different amounts of activity and incomplete reactions, varying stability of the biocatalyst in its various states, interfering side reactions due to other cellular activities, and so on. It is not clear to what extent reaction under each set of conditions was optimized or maximized. 

The product structure should be described in detail and there should be an estimate of the stability based on biological activity. The assays used to determine structure and stability will most likely be qualified, but not fully validated at this stage. Considerable thought must go into qualification of the methods upon which structure and stability are assessed at this early stage, however. One of the most important activities at this early stage is putting aside retention samples that are stored properly and can be used to evaluate the impact of process changes. 

The assessment of material quality normally starts with comparing a material s attributes to the specifications established by the purchasing company. Once the material satisfies established specifications, efforts are made to assess the stability of the product or intermediate manufactured with the material. Typically the determination of raw material process stability is made during the product development activities. Once a vendor or vendors have been selected, three distinct vendor lots of a given raw material will be purchased. Development batches of the product are then produced using these lots, and samples from the three batches are placed on stability. The thought is that if the materials from the three lots result in product with suitable stability profiles, the raw... 

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