Steve Mauch

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Purpose. This report summarizes the identification of nine deamidation and four hydrolysis products from a sample of pramlintide injection final drug product that was subjected to stress at 40°C for 45 days. Methods. The pramlintide degradation products were isolated by strong cation exchange HPLC followed by reversed-phase HPLC. Subsequent to isolation,(More)
We have investigated the biodistribution, toxicity, and antitumor activity of a new type of synthetic compound containing an enediyne functional group capable of benzenoid diradical generation. The design of this cytotoxic molecule was based on the structures of naturally occurring enediyne antibiotics. Compared to the natural compounds, the synthetic(More)
The naturally occurring enediyne antibiotics, which include calicheamicin, esperamicin, neocarzinostatin, kedarcidin and dynemicin, are a unique class of reactive compounds which can undergo aromatization to produce cytotoxic biradicals and can result in phosphodiester bond breakage of DNA. Synthetic enediynes designed with low molecular complexity are also(More)
This report summarizes the identification of six cyclic imide [Asu] and two deamidation products from a sample of pramlintide final drug product that had been stressed at 40 degrees C for 45 days. The pramlintide degradation products were isolated by cation exchange high-performance liquid chromatography (HPLC) followed by reversed-phase HPLC. The isolated(More)
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