General Chapter 2342 of the Chinese Pharmacopoeia 2025 Edition: Interpretation of the Standard Development for the Detection of Plant Growth Regulator Residues in Traditional Chinese Medicines

The intensive and unregulated application of plant growth regulators(PGRs) in the cultivation of Chinese medicinal materials has raised growing concerns regarding their potential residues, which may compromise both the safety and therapeutic efficacy of the final products. Currently, the lack of standardized analytical methods and maximum residue limits for PGRs in China hampers accurate risk assessment and effective regulatory enforcement. In response, the 2025 edition of the Chinese Pharmacopoeia introduces General Chapter 2342, establishing a three-tiered analytical framework for the detection of 65 PGRs. This study provides a systematic overview of PGR classifications, residue occurrence, and their impact on herbal quality; reviews international regulatory trends; and details the technical rationale, methodological features, and applicability of Chapter 2342. Furthermore, it discusses key challenges in comprehensive PGR management across the production chain and innovatively point out that the fundamental solution lies in shifting the regulatory logic from “food safety” to “drug efficacy”. The core pathway is to establish a TCM-specific PGRs regulatory classification system based on “medicinal part - residue risk - impact on efficacy”. The implementation of Chapter 2342 offers essential technical support for improving quality control and ensuring the safe use of PGRs in traditional Chinese medicine.