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These expectations include: Validated aseptic processing and/or sterile filtration Appropriate environmental monitoring and aseptic-process simulation (media fills) Control of light exposure, given the compound’s photolability Container–closure integrity verification Comprehensive quality control testing, including sterility, endotoxin, particulate matter, pH, and potency Regulators have emphasized that failure to meet these sterile-manufacturing requirements for compounded MeCbl may pose risks to patient safety

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