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6.Whatisthetotalorganiccarbon(TOC)limitforPurifiedWaterandWaterforInjection?

26. In <643> TOC, Sterile Water, for containers greater than 100 mL, if the result is between 8.00 – 12.00 mg/L of carbon, the chapter says that any component that is contributing 0.20 mg/L of carbon or higher must be identified, quantified, and have their safety profiles evaluated. How can this be accomplished?

Organic extractable components from the packaging that contribute to the TOC profile of the sterile packaged water should have been identified, quantified, and evaluated for safety/toxicity during packaging development activities in order for the packaging to have been approved by FDA. The methodologies used at that time could be the basis for any identification, quantification, and safety/toxicity studies needed for showing current compliance of sterile water product batches with their respective USP monographs. Additional guidance is available in General Chapters <661...