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Consequently, validated aseptic processing controls—validated sterile filtration, environmental monitoring, container–closure integrity assurance, and strict microbial and endotoxin specifications—are critical to ensuring the safety and quality of parenteral-grade solutions
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For context, tirzepatide demonstrated 22.5% weight reduction in the SURMOUNT-1 trial (NCT04184622) with 2,539 participants over 72 weeks [5]
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