LINEZOLID FORM II

Linezolid Form II is a high-purity oxazolidinone antibiotic used for the treatment of serious Gram-positive bacterial infections, including methicillin-resistant Staphylococcus aureus (MRSA), vancomycin-resistant Enterococci (VRE), and pneumonia. It works by inhibiting bacterial protein synthesis, providing potent bacteriostatic or bactericidal activity against resistant strains.

At Bluepill Express, we manufacture and export pharmaceutical-grade Linezolid Form II API that meets IP, BP, USP, and EP pharmacopeial standards. Produced under WHO-GMP, ISO, and cGMP-certified facilities, our API ensures high purity, polymorphic stability, and consistent particle size, suitable for tablets and oral suspensions.

Each batch undergoes stringent quality control, including HPLC, X-ray diffraction (for polymorphic confirmation), IR spectroscopy, and microbial testing, ensuring reliable and consistent performance for global pharmaceutical manufacturers.

Pharmacological Information:

• Therapeutic Class: Antibiotic / Oxazolidinone
• Pharmacological Category: Protein Synthesis Inhibitor
• CAS Number: 165800-03-3
• Molecular Formula: C16H20FN3O4
• Molecular Weight: 337.35 g/mol
• Appearance: White to off-white crystalline powder (Form II)
• Solubility: Soluble in water and methanol
• Melting Point: 177°C – 179°C (Form II)
• Storage: Store in a cool, dry place below 25°C, protected from light and moisture

Mode of Action:

Linezolid Form II binds to the 50S ribosomal subunit of bacteria, inhibiting the formation of the initiation complex for protein synthesis, which prevents bacterial replication. Its unique mechanism ensures activity against multi-drug-resistant Gram-positive pathogens.

Applications and Uses:

• Methicillin-Resistant Staphylococcus aureus (MRSA) infections
• Vancomycin-Resistant Enterococci (VRE) infections
• Hospital-acquired and community-acquired pneumonia
• Skin and soft tissue infections caused by Gram-positive bacteria
• Pharmaceutical Formulations – Oral tablets and suspensions

Technical Specifications:

• Assay (Purity): ≥ 99.0%
• Identification: IR, NMR, and X-ray diffraction confirm Form II polymorph
• Loss on Drying: ≤ 0.5%
• Residue on Ignition: ≤ 0.1%
• Heavy Metals: ≤ 10 ppm
• Particle Size: Optimized for tablet compression and suspension formulation
• Related Substances: ≤ 0.2% (individual impurity)
• Microbial Limits: Complies with pharmacopeial standards

Manufacturing & Quality Assurance – Bluepill Express:

• Produced under WHO-GMP, ISO 9001:2015, and cGMP-certified facilities
• Polymorphically stable Form II suitable for oral dosage forms
• COA, MSDS, and TDS provided with each batch
• HPLC and XRD-tested for purity and polymorphic integrity
• Pharmacopeial compliance: IP / BP / USP / EP

Packaging & Export Details:

• Available Packs: 1 kg, 5 kg, 10 kg, 25 kg HDPE drums with inner liner
• Shelf Life: 36 months from manufacturing date
• Labeling: Export-compliant with batch number and origin
• Export Markets: Africa, Asia, Europe, Middle East, Latin America
• Documentation Provided:
  • Certificate of Analysis (COA)
  • Material Safety Data Sheet (MSDS)
  • Technical Data Sheet (TDS)
  • Stability Data (on request)
  • Non-GMO & Allergen-Free Declarations