Variability in Excipients: Tylose in Microcrystalline Cellulose
Compatibility of excipients in drug products is demonstrated in accelerated and real-time stability programs, but too often batch-to-batch variability of excipients is ignored. Many excipients are derived through processing of natural animal, vegetable or mineral sources. Variability is introduced not only by process technology or process parameters, but also by inadequate specifications of starting materials; species of crop, different regional and seasonal provenance may contribute to batch-to-batch inconsistency. Excipia analyzed about 100 Microcrystalline Cellulose (MCC) samples from various manufacturers and grades for properties like molecular weight distribution, chemical composition, purity and chemical reactivity. We identified, amongst other things, a relation between the content of xylose and the reactive aldehyde furfural in MCC.
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