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Batch testing may include HPLC purity analysis, identity confirmation, and related analytical documentation depending on the current production batch

Hu Q, Xu J, Wang L, Yuan Y, Luo R, Gan M, et al

Reproductive toxicity studies of acetylcysteine solution in the rat given oral doses of acetylcysteine solution up to 1,000 mg/kg (5.2 times the human mucolytic dose) have also been reported in the literature.1 The only adverse effect observed was a slight non-dose-related reduction in fertility at dose levels of 500 or 1,000 mg/kg/day (2.6 or 5.2 times the human mucolytic dose) in the Segment I study

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