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Abstract:  The objective of this study was to determine the stability of metronidazole benzoate suspension in SyrSpend SF One-Step Suspension System. The studied samples were packaged in 60-mL amber plastic prescription bottles, which were stored protected from light under controlled environmental conditions for a period of 360 days. Stability of metronidazole benzoate suspension in SyrSpend SF was assessed based on retention of initial color or appearance, pH of suspension, and recovery of metronidazole benzoate from the packaged product. Duplicate samples were evaluated at each predefined time interval. An assay method by high performance liquid chromatography was validated for its specificity and stability-indicating characteristics through a forced-degradation study, and was used in metronidazole benzoate assay. Metronidazole benzoate in SyrSpend SF retained its normal appearance of an opaque suspension, with acceptable pH values ranging from 4.43 to 4.53 (range 4.45 ± 0.5). Recovery of metronidazole benzoate at sub

Related Keywords: Gary Schneider, RPh, FACA, stability, metronidazole, antibiotics, antimicrobial agents, commercial suspension system, storage

Related Categories: EXCIPIENTS, PEER-REVIEWED, STABILITIES, COMPATIBILITIES, INFECTIOUS DISEASE

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