Sterility: 비경구(주사) 제품에 대한 USP <71>/Ph.Eur. 2.6.1의 무균시험 요건을 충족함.
Bacterial Endotoxins: USP <85>/Ph.Eur. 2.6.14의 세균 내독소 기준을 충족하며, 검증된 LAL 시험으로 확인됨.
Particulate Matter: USP <788>/Ph.Eur. 2.9.19의 불용성 미립자 기준을 충족함.
Container Closure Integrity: 유효기간 동안 무균성 및 제품 완전성을 유지하도록 밸리데이션된 용기-마개 시스템.

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Ertapenem 1 g powder for concentrate for solution for infusion, referencing Invanz (MSD). Ertapenem is a carbapenem antibiotic indicated for pediatric patients and adults for infections caused by bacteria known or highly likely to be susceptible, when parenteral therapy is required, including intra-abdominal infections, community-acquired pneumonia, acute gynecological infections, and diabetic foot skin/soft-tissue infections, and in adults for prophylaxis against surgical site infection following elective colorectal surgery. The dossier is in progress with timelines to be defined, stability studies cover Zone II and Zone IVb, the originator's shelf life is two years, and batch and pack sizes are to be determined (originator packs of 1 or 10 vials).