SEM/EDX Profiling of Particulate Matter of Cefuroxime Powder for Injection

Abstract

Background: The current pharmacopeial requirement on subvisible particulate matter present in injections only considers its quantity. It does not take into account the nature and source of a particulate matter.

Objectives: This study aimed to profile the particulate matter present in four brands of Cefuroxime powder for injection commercially available in the Philippines.

Methods: The four brands were reconstituted in three experimental conditions. The solutions were filtered using a 0.45 μm polyethersulfone membrane filter to isolate the particulate matter. SEM/EDX was used to identify the particulate matter. The identification of the particulate matter was a result of integrating its size, morphology, chemical composition, and a comparison of the SEM/EDX outputs of the particulate matter with that of the known materials. The possible sources of the particulate matter were identified through literature review and experimentation.

Results: This study identified glass chips, glass lamellae, rubber fragments, polytetrafluoroethylene, fluorinated film coating, dolomite, paint, clay, undissolved Cefuroxime, silica powder, talc, calcium silicate, calcite, SS 316L, and a magnesium-rich particle. Brand D contained the most particulate matter types. Glass from the vials was the most common particulate matter followed by rubber, and calcium silicate.

Conclusion: There is no discernible trend in the type of particulate matter identified in the three experimental conditions. The sources of the particulate matter could not be precisely identified. The profiles may serve as a guide for the regulatory authority, sterile dosage form manufacturers, researchers, and healthcare professional directly involved in patient care.