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Chem228_LabReport - FDA Regulations Chemical Impurities in...

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FDA Regulations: Chemical Impurities in Antimalarial Compounds Chemistry 228 Lab Section 15 Instructor: Ken Tackett March 6, 2008 Abstact This report describes the identification of two impurities in a new drug, 3-(1- hydroxyethyl)aniline. The impurities occurred in the last step in the formation of the compound, a double reduction of m -nitroacetophenone. The compounds were synthesized by reacting m -nitroacetophenone with tin and hydrochloric acid, and with sodium borohydride. The impurities were identified after melting point was calculated and infra red spectroscopy, nuclear magnetic resonance, and thin layer chromatography tests were performed. The identities of the impurities were found to be 3-(1- hydroxyethyl)nitrobenzene in the reaction with sodium borohydride and 3- aminoacetophenone in the reaction with tin and hydrochloric acid. Introduction
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The US Food and Drug Administration (FDA) is responsible for setting guidelines to keep drugs safe for those who use them. One of the most important guidelines to which all pharmaceutical companies must pay close attention is the purity of the compound that they are using. It is very important for these companies to know everything that the patient will be consuming, including various impurities that may be in the final product. The drug must be at least 99.7% pure, but the 0.3% impurity level is only tolerated if the impurities are identified and shown to have no threat on the patient. The maximum level allowed for unknown impurities is only 0.01%. One company has developed a new drug, 3-(1-hydroxyethyl)aniline, but has not been able to identify the impurities. Our task is to identify the impurities, which we suspect came in the last step of the synthesis, a double reduction of m -nitroacetophenone. The task at hand will be to decide what compounds could be the contaminants, synthesize them from m -nitroacetophenone, and identify the impurities.
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