Excipients stability

Active Pharmaceutical Ingredients Stability Requirements for Excipients Stability Requirements for Drug Substances (APIs)... 

Cleland JL, Jones AJS. Excipient stabilization of polypeptides treated with organic solvents. U.S. Patent 1994, 5589167. 

Carrasquillo, K. G., Stanley, A. M., Aponte-Carro, J. C., DeJesus, P, Costantino, H. R., Bosques, C. J., and Griebenow, K. (2001), Non-aqueous encapsulation of excipient stabilized spray freeze dried BSA into poly(lactide-co-glycolide) microspheres results in release of native protein,/. Controlled Release,76,199-208. 

Examples of Excipient Stability Information Stability of Excipients—Bound and Unbound Water Conclusion... 

Excipient stability studies are generally not required to support the use of these materials. These materials have compendial standards and are suitable for their intended use. It is important, however, to understand the chemistry of the excipients so that the proper excipient can be used in a product. 

Some excipients may be similar in chemical structure to other excipients, and some may be mixtures or blends of other excipients. These excipients may be very similar to others within a product group. Minor quantitative differences of some of the components may be the only significant variation from one product to another. For these types of excipients, a model product approach may be appropriate to assess the stability of similar excipients. Stability studies of this type should involve selection of several model products that would be expected to simulate the stability of the product group being assessed. This selection must... 

The method of analysis (assay) should allow for determination of the content of the parent active substance and, if necessary, the amount of degradation product that is formed. Therefore, the assay should be specific, which means that it is able to quantify the parent substance in the presence of degradation products and excipients (stability indicating). The method has to be validated. 

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