Avoiding Common Flaws in Stability and Compatibility Studies of Injectable Drugs

Stability and compatibility of antimicrobial lock solutions

“…Studies were screened for the use of appropriate methods to confirm stability and compatibility. 13,14 Studies meeting the minimum methodology requirements and reporting standards included those using validated stability-indicating assays. 13,14 All review articles were excluded.…”

“…13,14 Studies meeting the minimum methodology requirements and reporting standards included those using validated stability-indicating assays. 13,14 All review articles were excluded. Case reports and case series, as well as clinical studies of ALT solutions commonly used in practice that did not meet the methodology criteria, were considered for discussion; if compatibility or stability was not discussed in these studies, we assumed that visual compatibility was assessed.…”

Compatibility of cefepime and vancomycin during simulated Y-site administration of prolonged infusion

“…Experiments were designed to conform with guidelines for assessing chemical stability and compatibility. [17][18][19] Cefepime for injection (2 g) a was prepared individually for each simulation directly from dry powder using the 100-mL Mini-Bag Plus system (Baxter Healthcare, Deerfield, IL) containing either 0.9% sodium chloride injection b or 5% dextrose injection c and immediately infused through i.v. tubing d at a constant rate of 0.4 mL/min.…”

Stability of an extemporaneous oral liquid aprepitant formulation

“…None of these degradation products interfered with aprepitant quantification. As a result of the chromatographic separation of these degradation products from aprepitant and the similarity of the UV spectrum (200-320 nm) between an authentic aprepitant standard and aprepitant in a degraded sample, it was concluded that this analytical method was stability indicating [11,12].…”

“…The purpose of this study was to develop a stable oral liquid formulation of aprepitant using the marketed aprepitant capsules. [11,12], test quantities of aprepitant 20-mg/mL oral liquid (six batches of 25 mL) were prepared separately. Each 25-mL test batch was stirred very well and immediately divided into two separate 12.5-mL samples which were packaged either in amber glass (Beatson Clark, Rotherham South Yorkshire, England; distributed by Richards Packaging, Toronto, Ontario) or amber polyethylene terephthalate (PET; Eastman Chemical Company, Kingsport, TN, USA; distributed by Jones Packaging Inc., Toronto, Ontario) prescription bottles.…”