Post-reconstitution Stability of Telavancin with Commonly Used Diluents and Intravenous Infusion Solutions.

Objective: The post-reconstitution chemical stability and microbial challenge hold time of nonpreserved telavancin for injection was determined using common reconstitution diluents and intravenous (IV) infusion solutions stored at room temperature with light (ambient) or at 2°C to 8°C without light (refrigeration).

Methods: Telavancin was reconstituted with 5% dextrose, 0.9% normal saline, or sterile water (15 mg/mL).

Characterization and resolution of reversed phase HPLC chromatography failure attributed to sulfobutylether-beta-cyclodextrin in a pharmaceutical sample preparation.

A reversed phase HPLC method developed for a drug product formulation using hydroxypropyl-beta-cyclodextrin (HPCD) was rendered ineffective for analyzing a similar formulation containing sulfobutylether-beta-cyclodextrin (SBECD). The active pharmaceutical ingredient (API) and the majority of its impurities became more strongly retained, eluting as an incoherent conglomerate of peaks. Furthermore, this phenomenon was reproduced in subsequent injections of the API reference standard.