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Bacteriostatic Water is manufactured to Water for Injection USP standards, requiring production by distillation or reverse osmosis from a suitable water source, testing for bacterial endotoxins below 0.25 EU/mL by the LAL method, sterility testing by membrane filtration to confirmed absence of microbial contamination, particulate matter testing below USP limits, pH within the 4.57.0 range, and osmolality confirmation consistent with a non-electrolyte aqueous solution

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10.1111/j.1471-4159.2009.06109.x J

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