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Indication of the HLA-B*58:01 allele was observed as the presence of peaks in the melt curve plot profile of the internal control and target allele region at 73.5C79C and 88.5C90C, respectively, or a single peak at 88.5C90C

It is governed by USP Chapter 797 standards for sterile compounding, and it factors in both chemical stability and sterility risk

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