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Moxalactam disodium compatibility with intramuscular and intravenous diluents
Abstract:
The stability of moxalactam disodium with mannitol injection in combination with intramuscular and intravenous diluents was investigated. Solutions were stored in original glass containers stoppered with butyl rubber closures or in polyvinyl chloride bags. Five diluents were evaluated at an intramuscular concentration of moxalactam 1 g (as the disodium salt) in 3 ml of diluent. Twenty intravenous diluents were evaluated with moxalactam 1 g (as the disodium salt) in 50 or 500 ml of diluent. High-performance liquid chromatography, polarography, thin-layer chromatography, spectrophotometric color evaluations, nephelometry, and pH determinations were performed. Solutions were assayed initially after reconstitution and stored for subsequent assay at refrigerator (5 degrees C) and room (25 degrees C) temperatures. The moxalactam disodium solutions were stable for up to 96 hours when stored at 5 degrees C or 24 hours when stored at 25 degrees C. The color, clarity, and TLC data were satisfactory for all diluent combinations tested. Polarographic, HPLC, and TLC data showed that the degradation products remained within acceptable limits when stored for 96 hours at 5 degrees C or 24 hours at 25 degrees C. The slight pH changes were within regulatory limits for moxalactam. The moxalactam disodium solutions maintained at least 90% of initial potency for up to 96 hours when stored in a refrigerator. If kept at room temperature, the reconstituted solutions should be used within 24 hours.
Insights
Moxalactam disodium injection stability was assessed with various diluents. The antibiotic injection remained stable for up to 96 hours refrigerated and 24 hours at room temperature.
Area of Science:
- Pharmaceutical Sciences
- Drug Stability
- Antibiotic Formulations
Background:
- Moxalactam disodium is a crucial antibiotic requiring careful handling.
- Understanding its stability in various diluents is vital for clinical use.
- Previous data on moxalactam disodium stability with common diluents is limited.
Purpose of the Study:
- To investigate the stability of moxalactam disodium injection.
- To evaluate stability in combination with intramuscular and intravenous diluents.
- To determine optimal storage conditions and timeframes for reconstituted solutions.
Main Methods:
- Moxalactam disodium solutions were prepared with five intramuscular and twenty intravenous diluents.
- Solutions were stored in glass containers or PVC bags at 5°C and 25°C.
- Stability was assessed using HPLC, polarography, TLC, spectrophotometry, nephelometry, and pH determination.
Main Results:
- Moxalactam disodium solutions maintained at least 90% potency for up to 96 hours at 5°C.
- Stability was limited to 24 hours at 25°C.
- Degradation products and physical characteristics remained within acceptable limits for tested combinations and storage durations.
Conclusions:
- Moxalactam disodium injection demonstrates good stability in various diluents under recommended storage conditions.
- Refrigerated storage (5°C) allows for up to 96 hours of stability.
- Room temperature storage (25°C) necessitates use within 24 hours.