Influence of moisture on stability of amoxicillin and potassium clavulanate granules / 中国药学杂志

ABSTRACT

OBJECTIVE: To investigate the influence of moisture including water content and water activity on the stability of amoxicillin and potassium clavulanate granules according to the characteristics of the granules, and reveal the key quality control property in the preparation process with stability as an indicator. METHODS: Under the condition of (25±2)℃ and (75±5)% RH, the water content, active ingredient contents, related substances and characteristics of crystal form of amoxicillin and potassium clavulanate granules were studied. RESULTS: The stability of amoxicillin and clavulante potassium granules was positively correlated with water activity in the samples, but was not related to water content closely. The sample with lower water activity was of higher stability. CONCLUSION: The key quality control property of amoxicillin and potassium clavulanate granules is the moisture, and the key process parameter in the preparation is the water activity.