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What are the specifications when we compare a fresh batch with a previous batch for growth promotion properties? Do we need to take a factor of 2 into account?

April 26, 2017batch compare Factor fresh growth previous promotion properties specifications

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What are the specifications when we compare a fresh batch with a previous batch for growth promotion properties? Do we need to take a factor of 2 into account?

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10 Posted

A. The factor of 2, as described in USP can be used. No strict requirement was deliberately given in this chapter because the test is qualitative, not quantitative. You can define the comparability criterion yourself. For example, colony size at the shortest incubation time prescribed. back to top Q.