Research on storage stability differences between ceftriaxone sodium products.

ABSTRACT: The conditions and mechanisms leading to stability differences between ceftriaxone sodium products were examined to ensure drug quality and efficacy. We used a combination of powder X-ray diffraction and thermogravimetric analysis to examine the differences between preparations for injection from different pharmaceutical processes to elucidate the changed processes by exposing samples to different humidity and high-temperature conditions. Water loss or absorption due to varying environmental humidity levels did not adversely affect the crystal structure, but could lead to the reversible redistribution of hepta-hydrate in the unit cell of generic products, causing its stability change. The irreversible distribution of hydrate may occur when generic drugs stored at 25 °C, whereas the brand-n

SUBMITTER: Qi S 

PROVIDER: S-EPMC10684491 | biostudies-literature | 2023 Nov

REPOSITORIES: biostudies-literature