SPL Set ID: 15dd51ed-29e8-468b-b6d1-21b1f84d6f2e

Paclitaxel Protein-Bound Particles for Injectable Suspension (albumin-bound) is paclitaxel, formulated as albumin-bound nanoparticles with a mean particle size of approximately 130 nanometers. Paclitaxel exists in the particles in a non-crystalline, amorphous state. Paclitaxel is a microtubule inhibitor. The chemical name for paclitaxel is 5β,20-Epoxy-1,2α,4,7β,10β,13α-hexahydroxytax-11-en-9-one 4,10-diacetate 2-benzoate 13-ester with (2 R ,3 S )- N -benzoyl-3-phenylisoserine. The molecular formula is C 47 H 51 NO 14 and the molecular weight is 853.91. Paclitaxel has the following structural formula: Paclitaxel is a white to off-white crystalline powder. It is highly lipophilic, insoluble in water, and melts at approximately 216°C to 217°C. Paclitaxel Protein-Bound Particles for Injectable Suspension (albumin-bound) is supplied as a white to yellow, sterile, lyophilized powder for reconstitution with 20 mL of 0.9% Sodium Chloride Injection prior to intravenous infusion. Each single-dose vial contains 100 mg of paclitaxel, approximately 900 mg of human albumin (containing sodium caprylate and sodium acetyltryptophanate), and approximately 23 mg sodium chloride. Each milliliter (mL) of reconstituted suspension contains 5 mg paclitaxel. Paclitaxel Protein-Bound Particles for Injectable Suspension (albumin-bound) is free of solvents. 1