N -亚硝基二甲胺(NDMA)

N-Nitrosodimethylamine is another carcinogenic compound, with particular focus placed on its detection and control in biologic and pharmaceutical products. Like NDEA, NDMA can form as a by-product during manufacturing processes. Regulatory agencies require its rigorous monitoring, and it plays a key role in ensuring the purity and safety of biologic products.

The United States Pharmacopeia (USP) provides quality standards for biologics to ensure their safety, efficacy, and quality throughout the manufacturing process. These standards assist manufacturers in adhering to regulatory requirements and help safeguard public health by reducing risks associated with biologics.