Applicability Test of Microbial Limit Test for Retapamulin Ointment

OBJECTIVE To establish and verify a method for the microbial limit test of Retapamulin ointment. METHODS The applicability test for Retapamulin ointment was conducted according to the microbial limit test in the general rules 1105 and 1106 of Chinese Pharmacopoeia (2015 Edition) Vol Ⅴ. Retapamulin ointment was dissolved with isopropyl myristate, and then filtrated by membran. After filtration, total count of aerobic bacteria, total count of molds and yeasts with reducing the amount of sample and adding Tween-80 in aqueous washing solution, the culture medium dilution method was used for control microorganisms test. RESULTS The recovery ratios of applicability test of total count of aerobic bacteria and total count of molds were in the range of 0.5-2. Staphylococcus aureus was not detected and Pseudomonas aeruginosa was detected in the applicability test of control microorganisms test. CONCLUSION In accordance with the provisions of Chinese Pharmacopoeia (2015 Edition), this method can be applied for the microbial limit test of Retapamulin ointment control.