N-Nitrosamine drug substance related impurities (NDSRIs) - A proposal for the addition of subcategories to carcinogenic potency categorization approach categories 1 and 2 for NDSRIs with a molecular weight > 200 Da.

The carcinogenicity potency categorization approach (CPCA) derived and harmonized by Health Authorities was a significant milestone, as it defined molecular properties that allowed for the rapid evaluation of the chemical structures of N-nitrosamine drug substance related impurities (NDSRIs) and the assignment of associated lifetime Acceptable Intake (AI) limits to inform on appropriate impurity control strategies in certain drug products. Nonetheless, it is important to continue to refine and improve on the CPCA based upon data-derived evidence. Herein, we focus on the default CPCA AI for NDSRIs, which is largely based on the small molecule N-nitrosamines (NAs).

Safety assessment of protein A and derivation of a parenteral health-based exposure limit.

Protein A (PA) is a bacterial cell wall component of Staphylococcus aureus whose function is to bind to Immunoglobulin G (IgG). Given its ability to bind IgG as well as its stability and resistance to harsh acidic and basic cleaning conditions, it is commonly used in the affinity chromotography purification of biotherapeutics. This use can result in levels of PA being present in a drug product and subsequent patient exposure.

Quantum Mechanical Assessment of Nitrosamine Potency.

Nitrosamines are in the cohort of concern (CoC) as determined by regulatory guidance. CoC compounds are considered highly potent carcinogens that need to be limited below the threshold of toxicological concern, 1.5 μg/day.

Zizyphus mauritiana seed extract: Paving the way for next-generation bone constructs with nano-fluorohydroxyapatite/carboxymethyl chitosan nanocomposite scaffold.

This is the first study that explored the potential use of Zizyphus mauritiana seed extract (ZSE) to synthesize nano-fluorohydroxyapatite/carboxymethyl chitosan nanocomposite scaffolds at different concentrations (CFZ1, CFZ2 and CFZ3) using co-precipitation method. The proposed scaffolds showed presence of intermolecular H bonding interactions between the constituents, according to the FTIR. The mechanical studies revealed shore hardness of 72 ± 4.