Tedizolid Phosphate is a phosphate prodrug of tedizolid belonging to the oxazolidinone class of antibacterial agents. It is converted in vivo to the pharmacologically active moiety, tedizolid, and is used for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible Gram-positive bacteria.
Tedizolid Phosphate is available for oral administration and intravenous infusion. The approved pharmaceutical product contains 200 mg of tedizolid phosphate per tablet or injection vial.
Tedizolid Phosphate has the molecular formula C17H16FN6O6P and a molecular weight of 450.32 g/mol. It is the phosphate prodrug of tedizolid and belongs to the oxazolidinone antibacterial class.
The pharmaceutical substance is chemically identified as the phosphate prodrug of the (5R)-configured tedizolid molecule. It is distinct from tedizolid free base and from the disodium salt form.
PubChem identifies CAS 856867-55-5, formula C17H16FN6O6P and molecular weight 450.3 g/mol; FDA labeling identifies the same molecular formula and a molecular weight of 450.32.
Tedizolid Phosphate is converted to tedizolid by phosphatases. The active tedizolid molecule binds to the 50S subunit of the bacterial ribosome, inhibiting bacterial protein synthesis.
Tedizolid demonstrates bacteriostatic activity against important Gram-positive organisms, including staphylococci, streptococci and enterococci.
Tedizolid Phosphate is used in pharmaceutical formulations for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible Gram-positive microorganisms.
The approved indication includes infections associated with:
The current U.S. labeling specifies use in adults and pediatric patients 12 years and older.
Tedizolid Phosphate API quality evaluation can include comprehensive analytical testing such as:
FDA regulatory documentation for tedizolid phosphate pharmaceutical products includes FTIR and HPLC identification, assay, degradation-product testing and loss-on-drying procedures.
Tedizolid Phosphate API manufacturing requires controlled chemical synthesis, stereochemical control, purification and validated analytical testing to ensure the required pharmaceutical quality attributes.
Particular attention is required for the correct phosphate form, stereochemical integrity and control of related substances and degradation products.
Tedizolid Phosphate should not be confused with tedizolid free base (CAS 856866-72-3) or tedizolid phosphate disodium salt (CAS 856867-39-5), which are chemically distinct substances.
Tedizolid Phosphate is reported as a white to yellow solid. Its molecular weight is 450.32 g/mol and its molecular formula is C17H16FN6O6P.
The marketed injectable formulation is supplied as a sterile white to off-white lyophilized powder. Following reconstitution, the solution has a reported pH range of 7.4–8.1.
Tedizolid Phosphate API should be packed in suitable well-closed, light-protective pharmaceutical containers that minimize exposure to moisture, light and contamination.
Available pharmaceutical-quality specifications describe storage in well-closed, light-resistant and airtight containers.
For finished pharmaceutical products, storage should follow the validated product-specific stability conditions. The marketed SIVEXTRO product is stored at controlled room temperature of 20°C to 25°C, with permitted excursions to 15°C to 30°C.
Typical documentation for Tedizolid Phosphate API may include:
A reliable Tedizolid Phosphate API manufacturing partner should maintain controlled manufacturing processes, validated analytical methods, appropriate impurity controls and complete quality documentation.
Swapnroop focuses on pharmaceutical-grade API solutions supported by quality-oriented manufacturing and analytical practices. Tedizolid Phosphate can be supplied according to customer-specific pharmaceutical, regulatory and documentation requirements.
| Parameter | Specification |
|---|---|
| Appearance | white to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.0% – 102.0% |
| Loss on Drying | NMT 2.0% |
| Residue on Ignition | NMT 0.1% |
| Heavy Metals | NMT 10 ppm |
| Individual Impurity | NMT 0.10% |
| Total Impurities | NMT 0.5% |
| Water Content | NMT 1.0% |