Sterility: Cumple con los requisitos del ensayo de esterilidad según USP <71>/Ph.Eur. 2.6.1 para productos parenterales.
Bacterial Endotoxins: Cumple con los límites de endotoxinas bacterianas según USP <85>/Ph.Eur. 2.6.14, confirmados mediante ensayo LAL validado.
Particulate Matter: Cumple con los límites de partículas subvisibles según USP <788>/Ph.Eur. 2.9.19.
Container Closure Integrity: Sistema de cierre del envase validado para mantener la esterilidad e integridad del producto durante toda su vida útil.

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Descripción adicional:

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).