Application of Water Activity to Microbial Control Strategy of Fengliao Changweikang Preparations
The quality and safety of non-sterile pharmaceutical products are affected by microbial contamination,so the microbial contamination control is an important measure to ensure the safety of pharmaceuticals.Water activity is a key physicochemical parameter that affects the growth and reproduction of microorganisms,and it can be easily,accurately and rapidly determined.Controling the water activity in an appropriate range would help to inhibit the growth and reproduction of microorganisms.This study established a microbial control strategy by determining water activity values of herbs and excipients,intermediate products,and final products of Fengliao Changweikang preparations,and combining with the risk assessment of the production process.This study provided a new idea for the microbial control of non-sterile pharmaceutical products and the development of standards.
water activityFengliao Changweikang preparationisothermal curve of water adsorptionmicrobial controlquality control
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