Sterilization Process Of Clindamycin Phosphate And Sodium Chloride Injection

Clindamycin phosphate is the clindamycin ramification which is synthesized through the chemical method. The most clinics dosages are injection,lyophilized powder for injection,troche,capsule etc. The dosage of firm is Large volume parenteral solution. As clindamycin phosphate is an ester, high-temperature and terminal moist heat sterilization which is needed after canning during the procedure of production can hydrolyze the 2-hydroxide easily, it can make the related substance disqualification. Assuring the related substance eligibility, the lower temperature and shorten time should be adopted. But as the"Chinese pharmacopoeia"of 2000 says the demand of sterilization and sterility assurance is that the sterility assurance level(SAL)should GE 6 through the moist heat sterilization process, just the coincidental products can be released. It is desired that under the assurance of products quality we should adopt the sterilization term as intense as possible. Considering the every condition, we explore the suitable process of sterilization.The factors which affect the hydrolyzed rate of clindamycin phosphate are pH,temperature and time. This text introduces several method of sterilization at first, via reviewing the degraded rate in the different pH,temperature and time to screen out some program of sterilization that can insure the related substance eligible; in order to achieve the regulation of , we adopt the survival probability sterilization process and choose Clostridium sporogenes as biological indicator to test D value at the different temperature.Through analyzing the experimental data, we confirm the term of 110℃and 20 minutes as the proper process of sterilization; At this base further validating three batches of products, the rationality and reliability of this sterilization process is affirmed.Many products can't be sterilized through overheat sterilization in large volume parenteral solution. It is discussed the products which always can endure the sterilized standard time (F₀) more than 8 minutes, and less can endure the time less than 8 in most literatures. This test tells the review of concern factors which affects the Clindamycin phosphate sodium chloride injection through series of experiment, and the sterilized curve concern the eligible substance is gained. Combining the validation of biological indicator, we affirm the condition by which we can achieve...