Antioxidants and Reducing Agents
| Excipient | Frequency | Range | Example |
|---|---|---|---|
| Acetone sodium bisulfite | 4 | 0.2–0.4% w/v | Novocaine® (Sanofi-Winthrop) 0.4% w/v |
| Argon | - | 100% | Used to fill headspace of lyophilized or liquid products. TechneScan MAG3® (Covidien) |
| Ascorbyl palmitate | 1 | Visudyne® (QLT) | |
| Ascorbate (sodium/acid) | 10 | 0.1–4.8% w/v | Vibramycin® (Pfizer) 4.8% w/v |
| Bisulfite sodium | 31 | 0.02–0.66% w/v | Amikin® (Bristol Myers) 0.66% w/v |
| Butylated hydroxy anisole (BHA) | 3 | 0.00028–0.03% w/v | Aquasol A® (Astra) 0.03% w/v |
| Butylated hydroxy toluene (BHT) | 4 | 0.00116–0.03% w/v | Aquasol A® (Astra) 0.03% w/v |
| Cystein/cysteinate HCl | 4 | 0.07–1.3% w/v | Acthrel® (Ferring) 1.3% w/v |
| Dithionite sodium (Na hydrosulfite, Na sulfoxylate) | 1 | 0.10% | Numorphan® (Endo Lab) 0.10% |
| Gentisic acid | 1 | 0.02% w/v | OctreoScan® (Mallinckrodt) 0.02% w/v |
| Gentisic acid ethanolamine | 1 | 2% | M.V.I. 12® (Astra) 2% |
| Glutamate monosodium | 1 | 0.1% w/v | Varivax® (Merck) 0.1% w/v |
| Glutathione | 1 | 0.01% w/v | Advate® (Baxter) 0.01% w/v |
| Formaldehyde sulfoxylate sodium | 10 | 0.075–0.5% w/v | Terramycin solution (Pfizer) 0.5% w/v |
| Metabisulfite potassium | 1 | 0.10% | Vasoxyl® (Glaxo-Wellcome) 0.10% |
| Metabisulfite sodium | 33 | 0.02–1% w/v | Intropin® (DuPont) 1% w/v |
| Methionine | 5 | 0.01–0.15% | Depo-subQ provera 104 (Upjohn) |
| Monothioglycerol (Thioglycerol) | 8 | 0.1–1% | Terramycin solution (Pfizer) 1% |
| Nitrogen | - | 100% | Used to fill headspace of lyophilized or liquid products |
| Propyl gallate | 3 | 0.02% | Navane® (Pfizer) 0.02% |
| Sulfite sodium | 8 | 0.05–0.2% w/v | Enlon® (Ohmeda) 0.2% w/v |
| Tocopherol alpha | 2 | 0.005–0.075% | Torisel (Wyetth) 0.075% |
| α-Tocopherol hydrogen succinate | 1 | 0.02% w/v | Fluarix® (GSK) 0.02% w/v |
| Thioglycolate sodium | 1 | 0.66% w/v | Sus-Phrine® (Forest) 0.66% w/v |