Additional information on N-Nitroso Desmethyl Bedaquiline
FDA Potency Category 1 NDSRI
26.5 ng/day is the U.S. FDA’s current Acceptable Intake (AI) limit for N-nitroso-desmethyl-bedaquiline (NDSRI). Refer to the FDA nitrosamine page for the latest guidance.
N-Nitroso Desmethyl Bedaquiline is an N-nitroso derivative of the secondary amine present in Bedaquiline | which is a highly characterized reference material that meets stringent regulatory standards set for nitrosamine compounds | including those set by USP | EMA | JP | and BP. This nitroso standard is essential for a variety of applications | such as analytical method development | method validation (AMV) | and Quality Control (QC) | particularly in the context of Bedaquiline production. It is suitable for use in both Abbreviated New Drug Applications (ANDA) and New Drug Applications (NDA). This nitrosamine standard helps establish detection limits | quantify impurity levels | and ensure trace nitroso impurities in pharmaceutical products remain within FDA and EMA safety limits.
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