Linezolid Form II is a specific anhydrous crystalline polymorphic form of Linezolid, an oxazolidinone-class antibacterial active pharmaceutical ingredient (API). Linezolid Form II is characterized by its defined crystal structure and solid-state properties and is used in pharmaceutical API manufacturing and formulation development.
Linezolid has the CAS Number 165800-03-3, molecular formula C16H20FN3O4 and molecular weight 337.35 g/mol. Form II represents a specific polymorphic crystal form of the same Linezolid molecule and does not have a separate molecular formula or molecular weight.
Linezolid is a synthetic oxazolidinone antibacterial compound. Linezolid Form II is an anhydrous polymorph distinguished from other crystal forms by its powder X-ray diffraction pattern, thermal behavior and solid-state characteristics.
Polymorphism is important for pharmaceutical APIs because different crystal forms of the same compound can have different physical properties such as melting behavior, stability, solubility and dissolution characteristics. Linezolid Form II has been characterized using X-ray diffraction, differential scanning calorimetry and other solid-state analytical techniques.
Linezolid inhibits bacterial protein synthesis by binding to the bacterial 50S ribosomal subunit. It prevents formation of the functional initiation complex required for protein synthesis, thereby inhibiting bacterial growth.
Swapproop Drugs and Pharmaceuticals supports the sourcing and supply of Linezolid Form II API for qualified pharmaceutical requirements. Linezolid Form II can be evaluated using applicable pharmacopoeial specifications together with solid-state characterization appropriate for polymorphic API control.
For Linezolid Form II API availability, technical documentation, specifications and commercial requirements, contact Swapproop Drugs and Pharmaceuticals.
| 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 0.5% |
| Individual Impurity | NMT 1.0% |
| Total Impurities | NMT 2.0% |
| Water Content | NMT 1.0% |