USP general chapter <561> Articles of Botanical Origin undergoes major revision (USP)

The United States Pharmacopeia (USP) has revised general chapter <561> Articles of Botanical Origin in two areas through Pharmacopeial Forum (PF). First (PF 52(4)), the water determination methods have been revised: instead of azeotropic distillation with toluene, traditionally used for samples containing volatile components (considered environmentally hazardous because it uses a large volume of a toxic solvent and high temperature), the more environmentally friendly Karl Fischer titration (with formamide extraction) is proposed; the revised chapter includes three methods. Second (PF 52(5)), requirements for polycyclic aromatic hydrocarbons (PAHs) have been added to the chapter: not more than 10.0 µg/kg for benzo[a]pyrene and not more than 50.0 µg/kg for the sum of benzo[a]pyrene, chrysene, benz[a]anthracene and benzo[b]fluoranthene; the analysis is performed by gas chromatography with quadrupole time-of-flight mass spectrometry (GC-QTOF-MS). The PAH changes become official on 1 December 2026.

This review was prepared for the News section of the journal «Oʻzbekiston farmatsevtik xabarnomasi» (Pharmaceutical Bulletin of Uzbekistan).

Source: doi.usp.org