Bupropion - Isotope Labelled Standards

Impurity testing should be conducted at regular intervals during drug development, including during the synthesis of the API, production of drug products, and stability studies. The testing frequency depends on the regulatory requirements and the risk associated with the impurities.

Yes, impurities in Bupropion can affect the drug efficacy by reducing the potency of the API or interfering with its mechanism of action.

The detection of impurities in Bupropion is through analytical methods such as high-performance liquid chromatography (HPLC), liquid chromatography-mass spectrometry (LC-MS), etc.

Bupropion impurities are stored at a controlled room temperature between 2-8 °C or as indicated on the Certificate of Analysis (CoA).