bortezomib injection 1 MG and 2.5 MG VIAL Description
(bortezomib for injection)
11 DESCRIPTION
Bortezomib for Injection, a proteasome inhibitor, is an antineoplastic agent. Bortezomib is a modified dipeptidyl boronic acid. The chemical name for bortezomib, the monomeric boronic acid, is [(1R)-3-methyl-1-[[(2S)-1-oxo-3-phenyl-2[(pyrazinylcarbonyl) amino]propyl]amino]butyl] boronic acid.
Bortezomib has the following chemical structure:
The molecular weight is 384.24 g/mol. The molecular formula is C19H25BN4O4. The solubility of bortezomib, as the monomeric boronic acid, in water is 3.3 to 3.8 mg/mL in a pH range of 2 to 6.5.
Bortezomib for Injection is available for intravenous injection or subcutaneous use. Each single-dose vial contains 1 mg or 2.5 mg of bortezomib as a sterile lyophilized powder. It also contains the inactive ingredient: 10 mg or 25 mg mannitol, USP for the 1 mg and 2.5 mg single-dose vial, respectively. The product is provided as a mannitol boronic ester which, in reconstituted form, consists of the mannitol ester in equilibrium with its hydrolysis product, the monomeric boronic acid. The drug substance exists in its monohydrate form.
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Description
11 DESCRIPTION
Bortezomib for Injection, a proteasome inhibitor, is an antineoplastic agent. Bortezomib is a modified dipeptidyl boronic acid. The chemical name for bortezomib, the monomeric boronic acid, is [(1R)-3-methyl-1-[[(2S)-1-oxo-3-phenyl-2[(pyrazinylcarbonyl) amino]propyl]amino]butyl] boronic acid.
Bortezomib has the following chemical structure:
The molecular weight is 384.24 g/mol. The molecular formula is C19H25BN4O4. The solubility of bortezomib, as the monomeric boronic acid, in water is 3.3 to 3.8 mg/mL in a pH range of 2 to 6.5.
Bortezomib for Injection is available for intravenous injection or subcutaneous use. Each single-dose vial contains 1 mg or 2.5 mg of bortezomib as a sterile lyophilized powder. It also contains the inactive ingredient: 10 mg or 25 mg mannitol, USP for the 1 mg and 2.5 mg single-dose vial, respectively. The product is provided as a mannitol boronic ester which, in reconstituted form, consists of the mannitol ester in equilibrium with its hydrolysis product, the monomeric boronic acid. The drug substance exists in its monohydrate form.
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