Linezolid is a synthetic oxazolidinone active pharmaceutical ingredient designed for the treatment of severe infections caused by aerobic Gram-positive bacteria, including methicillin-resistant Staphylococcus aureus (MRSA) and vancomycin-resistant enterococci (VRE). Acting through the inhibition of the initiation process of bacterial protein synthesis, it binds to the 50S ribosomal subunit, preventing the formation of the functional 75S initiation complex. Manufactured via optimized chemical synthesis routes, this API provides high purity profiles required for downstream sterile injectable and oral solid dosage formulations.
Product Information
|
Parameter |
Specification Details |
|
Chemical Name |
N-[[(5S)-3-[3-fluoro-4-(4-morpholinyl)phenyl]-2-oxo-5-oxazolidinyl]methyl]acetamide |
|
CAS Number |
165800-03-3 |
|
Molecular Formula |
C16H20FN3O4 |
|
Molecular Weight |
337.35 g/mol |
|
Appearance |
White to off-white crystalline powder |
|
Solubility |
Practically insoluble in water, slightly soluble in methanol |
|
Storage Conditions |
Store in tight containers, protected from light, at controlled room temperature |
Quality & Specification
|
Test Parameter |
Acceptance Criteria (In-House / Pharmacopeial Standard) |
|
Assay (Calculated on Dried Basis) |
98.5% - 101.5% |
|
Identification |
Conforms to IR and HPLC retention time |
|
Appearance of Solution |
Clear and colorless (in specified solvent) |
|
Water Content |
≤ 0.5% |
|
Residue on Ignition |
≤ 0.1% |
|
Heavy Metals |
≤ 20 ppm |
|
Individual Unknown Impurity |
≤ 0.10% |
|
Total Impurities |
≤ 0.5% |
|
Residual Solvents (GC) |
Compliant with ICH Q3C limits |
Manufacturing & Supply
|
Operational Metric |
Technical Specification |
|
Production Scale |
Commercial metric tons per annum |
|
Batch Size Capability |
Standard multi-hundred-kg production batches |
|
Synthetic Route |
Non-infringing, optimized chiral synthesis |
|
Containment Level |
Dedicated multi-purpose synthesis and micronization facilities |
|
Supply Stability |
Multi-sourcing of key raw materials to secure uninterrupted output |
Documentation
Regulatory Dossier: DMF (Drug Master File) available for reference.
Quality Certificates: Certificate of Analysis (CoA) provided with every commercial batch.
Compliance Data: ICH Q3A/Q3B impurity profile reports, residual solvent validation data, and elemental impurity assessments (ICH Q3D).
Supply Chain Statements: TSE/BSE-free declaration, GMO-free statement, and melamine-free verification.
Packaging
|
Primary Packaging |
Double-layer food-grade low-density polyethylene (LDPE) bags, heat-sealed. |
|
Secondary Packaging |
Fiber drum or rigid high-density polyethylene (HDPE) container equipped with desiccant sachets between layers. |
|
Standard Net Weight |
25 kg/drum. |
|
Customization |
Alternative container configurations available upon technical agreement. |
Pharmaceutical Application
Oral Tablet Formulations: Utilized as the active core component for immediate-release solid oral dosage forms. Formulation stability and predictable dissolution rates support consistent bioavailability profiles in finished products.
Oral Suspension Formulations: Integrated into pediatric and dysphagic patient-centric liquid delivery systems. Controlled particle size distribution ensures uniform suspension stability and accurate dosing.
Intravenous Infusion Solutions: Processed for sterile hospital-grade parenteral administration in critical care settings. Low bioburden and strict endotoxin limits facilitate downstream sterile filtration and terminal sterilization.
FAQ
Q: What is the regulatory status of your Linezolid API?
A: The product is manufactured in compliance with cGMP guidelines, and a comprehensive DMF is available for regulatory review to support customer filings.
Q: What particle size distribution (PSD) options are available?
A: Standard micronized (d90 < 10 µm) and unmicronized grades are supplied depending on whether the downstream process requires direct compression or wet granulation.
Q: What is the standard shelf life and retest period?
A: The established retest period is 36 months when stored under the recommended packaging and environmental conditions.
Q: Are reference standards provided for analytical method validation?
A: Validated analytical working standards and related impurity reference compounds can be supplied upon request alongside commercial orders.
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