Tedizolid is an oxazolidinone-class antibacterial agent used in its phosphate prodrug form, Tedizolid Phosphate. Tedizolid phosphate is converted in vivo to the active moiety tedizolid and is used for the treatment of acute bacterial skin and skin structure infections caused by susceptible Gram-positive bacteria.
Tedizolid phosphate has the molecular formula C17H16FN6O6P, a molecular weight of approximately 450.3 g/mol, and CAS Number 856867-55-5. It is also known by the development codes TR-701 FA and DA-7157 phosphate.
Tedizolid belongs to the oxazolidinone class of antibacterial compounds. The phosphate group forms a water-compatible prodrug that is converted to active tedizolid following administration.
CAS Number: 856867-55-5
Molecular Formula: C17H16FN6O6P
Molecular Weight: 450.3 g/mol
Active Moiety: Tedizolid
Development Code: TR-701 FA
Therapeutic Class: Oxazolidinone Antibacterial
API Type: Small-Molecule Antibacterial API
The free active moiety, Tedizolid, has CAS 856866-72-3, formula C17H15FN6O3 and molecular weight 370.3 g/mol. The pharmaceutical phosphate form should be distinguished from the free active moiety.
After conversion to active tedizolid, the molecule inhibits bacterial protein synthesis by binding to the 50S ribosomal subunit. It interferes with formation of the functional initiation complex required for bacterial protein synthesis.
Tedizolid demonstrates antibacterial activity against susceptible Gram-positive organisms, including strains of Staphylococcus aureus, Streptococcus species and Enterococcus faecalis. Tedizolid phosphate is therefore classified as an oxazolidinone antibacterial prodrug.
Tedizolid phosphate is used for the treatment of acute bacterial skin and skin structure infections caused by susceptible Gram-positive bacteria.
Its antibacterial spectrum includes susceptible strains of Staphylococcus aureus, including methicillin-resistant and methicillin-susceptible strains, selected Streptococcus species and Enterococcus faecalis.
Tedizolid phosphate may be supplied for pharmaceutical formulation and development applications where the appropriate regulatory and quality requirements are met.
Tedizolid phosphate is a stereochemically defined small-molecule API and requires comprehensive pharmaceutical quality control.
Typical quality evaluation may include:
The exact numerical acceptance criteria should be taken from the applicable approved, pharmacopoeial or validated manufacturer specification for Tedizolid Phosphate.
Swapnroop Drugs and Pharmaceuticals is an India-based pharmaceutical manufacturing organization supporting pharmaceutical customers with quality-focused API manufacturing and analytical documentation.
Tedizolid Phosphate is a specialized antibacterial API requiring controlled synthesis, stereochemical control, impurity profiling, chromatographic assay and appropriate pharmaceutical documentation.
The exact chemical form should be clearly identified in the product specification and Certificate of Analysis to distinguish Tedizolid Phosphate from the active free moiety.
Tedizolid Phosphate should be packaged in suitable pharmaceutical-grade containers that protect the API from moisture, contamination and environmental exposure.
Storage conditions, packaging configuration, retest period and transportation requirements should follow validated stability data and the applicable product specification.
Documentation for Tedizolid Phosphate API may include:
| Parameter | Specification |
|---|---|
| Appearance | white to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.0% – 102.0% |