Nitrosamines in Biologics

Enclosed is an interesting article related to Nitrosamines in Biologics.

HN-HS-GLO-Biologics-Nitrosamines-WP-2.pdf (2.9 MB)

1 Like


contrary to the currently held belief that nitrosamine risk factors for biologics are marginal. This position is supported by a number of important considerations including:
(i) Generally, the high water purity used for the manufacturing, formulation and storage of biologics
minimizes this source of potential nitrosating agents such as nitrates.
(ii) Purification procedures, often based on molecular size, minimize the potential for low molecular mass impurities.
(iii) Biologics are usually processed and stored using conditions that do not favor nitrosamine formation.
(iv) The in vivo generation of potentially mutagenic species from a nitrosated biologic API is considered very unlikely.
(v) Paradoxically, while biologics often do contain multiple reactive sites for nitrosamine formation, their molar abundance and type transforms such products into scavengers – actually reducing the effects from potential nitrosating agents (11). The European Federation of Pharmaceutical Industries and Associations has released a comprehensive review of these factors (12).