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Utilize the dissolution medium specified in the individual monograph. If the medium is really a buffered solution, change the answer so that its pH is in 0.05 units of the pH laid out in the monograph. The dissolution medium must be deaerated previous to testing.In addition to the popular analytical overall performance attributes Generally evaluate
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Remember, the pharmacopoeias usually are not harmonized for environmental monitoring and every has different necessities that desire really minimal Preliminary contamination recovery fees or perhaps the detection of really very low cfu amounts (Tables 1 and a pair of). The requirements differ depending on the criticality on the production location
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