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As a result, 503B facilities often assign longer BUDs, sometimes 60-90 days or more, because they have the data to support those extended dates

For example, injectable pyridoxine solutions may contain aluminum as a trace impurity, and with prolonged use in patients with renal impairment (especially premature neonates with immature kidneys) there is a risk of aluminum accumulation and toxicity

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Pharmacokinetics and dosage adjustment in patients with hepatic dysfunction