The risk evaluation of nitrosated agents centers on nitrosamines, which belong to a high-risk nitrosamine chemical hazard class and are widely recognized as genotoxic impurities due to their DNA-damaging and carcinogenic potential.

Nitrosamine degradation products are formed when unstable N-nitroso compoundsbreak down in pharmaceutical formulations or environmental matrices

Nitrosamine degradation products are formed when unstable N-nitroso compoundsbreak down in pharmaceutical formulations or environmental matrices

Nitrosamine-class chemicals are organic substances containing a nitroso (–N–N=O) group bonded to an amine.

Nitrosamine compounds are a critical quality concern because many are potentially carcinogenic and can be harmful even at very low levels, making their control essential in pharmaceuticals

Embryo-fetal toxicity refers to harmful effects on a developing embryo or fetus due to exposure to certain substances, such as medications, chemicals, or environmental factors.

Fluid retention, also known as water retention, occurs when excess fluid builds up in the body's tissues, causing swelling often in the hands, feet, ankles, or legs.

Testosterone is a vital hormone that plays a key role in muscle growth, energy levels, mood, and sexual health.

Mineralocorticoids are hormones produced by the outer layer of the adrenal glands that help control the body's balance of salt, water, and electrolytes.

Hypoglycemia occurs when blood sugar levels fall too low, depriving the body—and especially the brain—of its main energy source. A blood glucose level under 70 mg/dL is generally considered hypoglycemic.