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Characterization: "Not Well-Characterized" FDA concluded that both the free base and acetate forms are not well-characterized physically and chemically, citing (1) inconsistent naming conventions that do not follow established nomenclature standards (USAN, INN, IUPAC), and (2) missing substance-specific quality-control data
27 In general, patients with an irreversible cause should be treated indefinitely, whereas those with a reversible cause should be treated until the deficiency is corrected and symptoms resolve
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This 28-day limit applies even if the expiration date is months away
