Shelf lives of aseptically prepared medicines--stability of netilmicin injection in polypropylene syringes.
There is no published information on the stability of netilmicin solutions in prefilled syringes. The purpose of this study was to evaluate the stability of netilmicin in polypropylene syringes and to determine the optimum validated shelf life so that they may be prepared in bulk in appropriately licensed facilities. The syringes containing netilmicin 10 or 100mg/ml were stored at 7 degrees C, room temperature in the light (RTL) and 25 degrees C/60% relative humidity for up to 300 days. Netilmicin concentration was determined by reversed phase high performance liquid chromatography (RP-HPLC) of the isoindole derivative formed with o-phthalaldehyde (OPA). The shelf lives were calculated using the maximum rate method applied to the netilmicin analytical data. At 7 degrees C 10 and 100mg/ml solutions were stable for 90 days falling to 30 days at 25 degrees C and 60% RH. At RTL the 10mg/ml solution was stable for 9 days.
Rigge
Diane Clare
DC
Quality Control North West, Stepping Hill Hospital, Poplar Grove, Stockport, Cheshire SK2 7JE, UK. diane.rigge@stockport-tr.nwest.nhs.uk
Jones
Martin Frederick
MF
D000900:Anti-Bacterial Agents / Q000008:administration & dosage / Q000032:analysis / Q000737:chemistry; D001207:Asepsis; D002851:Chromatography, High Pressure Liquid; D004355:Drug Stability; D004356:Drug Storage; D009428:Netilmicin / Q000008:administration & dosage / Q000032:analysis / Q000737:chemistry*; D011126:Polypropylenes; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D013594:Syringes; D013696:Temperature
D000900:Anti-Bacterial Agents; D011126:Polypropylenes; D009428:Netilmicin