The harmonization of the microbial limits test enumeration. Description of categories gov, and material safety data sheets msdss are available to compounding personnel for all drugs and chemicals used in compounding. Before the introduction of the harmonized chapter 1111, usp was only interested in specified organisms. Due to its extreme length, table 2 is provided here as a. Usp general chapter 1111 acceptance criteria for pharmaceutical preparations and drug substances for pharmaceutical use is practically harmonized with the ep section 5. The microbial limits tests are actually two chapters in the current usp. Limits tests usp 2006b and microbiological attributes of nonsterile. Microbial examination of nonsterile products is performed according to the methods given in the texts on microbial. Microbiological examination microbiological tests usp 31 fatty productsdissolve in isopropyl myristate sterilized bygauze to prevent the patches from sticking together, and transfer filtration, or mix the product to be examined with the minimumthe patches to a suitable volume of the chosen diluent containing.
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