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Dr. Shaquille presents lab research showing antioxidants and pH control can reduce nitrosamine formation
Summary
Dr. Shaquille of CDER's Office of Pharmaceutical Quality Research summarized lab studies showing multi-layered mitigation – supplier controls, antioxidants, pH modifiers and drying/temperature control – can reduce nitrosamine formation, but effectiveness depends on drug chemistry and manufacturing conditions.
Dr. Shaquille, a doctor in the Office of Pharmaceutical Quality Research at the Center for Drug Evaluation and Research (CDER), described laboratory work aimed at understanding nitrosamine formation mechanisms and testing practical mitigations.
He said mitigation must be multi-layered, beginning with API manufacturing controls and supplier qualification to limit nitrite impurities in excipients, and adding antioxidants, pH modifiers and tighter manufacturing controls. "Antioxidant can effectively mitigate nitrosamine formation, but they must be fit for purpose," he said, and noted their effectiveness depends on drug-substance chemistry, formulation design and manufacturing conditions. He also emphasized that heat and moisture during steps such as wet granulation and drying significantly increase formation, making drying controls critical.
