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ANFARM HELLAS S.A. sell "Ceftriaxone Ps.Inj.Sol 1g/Vial (IM, IV) (EU CTD Available)"

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Product Name

Ceftriaxone Ps.Inj.Sol 1g/Vial (IM, IV) (EU CTD Available)

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Specifications

  • Sterility: Sterile; complies with USP <71> / Ph. Eur. 2.6.1 sterility test requirements.
  • Bacterial Endotoxins: Bacterial endotoxins ≤ 0.5 EU/mL, per USP <85> / Ph. Eur. 2.6.14 (LAL test).
  • Particulate Matter: Meets USP <788> / Ph. Eur. 2.9.19 limits for sub-visible particulate matter in parenteral solutions.
  • Container Closure Integrity: Glass vial with rubber stopper and aluminium flip-off seal; verified for closure integrity
  • Content Uniformity: Complies with USP <905> / Ph. Eur. 2.9.40 content uniformity acceptance criteria (acceptance value ≤ 15).

Other Information

Additional Description:

This ceftriaxone powder for solution for injection/infusion (1 g/vial), referencing Farcef (Angelini), is a cephalosporin antibacterial for lower respiratory tract infections, skin and skin structure infections, complicated and uncomplicated urinary tract infections, pelvic inflammatory disease, bacterial septicemia, bone and joint infections, intra-abdominal infections, meningitis, and surgical prophylaxis caused by susceptible organisms. An EU CTD dossier is available, with stability data for Zone II/IVb, a two-year shelf life, a batch size of 42,052 vials, and packs of one vial per box.
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