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Specialty Journal of Pharmacognosy, Phytochemistry, and Biotechnology

2026 Volume 6 Issue 1

Batch Equivalence Should Preserve Chemical Function, Not Only Fingerprint Similarity: A Multiscale Quality Model for Complex Herbal Preparations Across Manufacturing Drift


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  1. Department of Herbal Quality and Multiscale Equivalence, College of Pharmacy, Kyung Hee University, Seoul, South Korea.
  2. Department of Chemical Function Preservation, College of Pharmacy, Chung-Ang University, Seoul, South Korea.
  3. Department of Manufacturing Drift and Quality Control, College of Pharmacy, Kangwon National University, Chuncheon, South Korea.
Abstract

Batch-to-batch consistency in complex herbal preparations is commonly judged through identity tests, marker assays, chromatographic fingerprints, and multivariate similarity. These approaches are essential for chemical quality control, yet they do not by themselves establish that manufacturing or storage variation has preserved the chemical features most relevant to biological function. This article develops an original quality-equivalence model that reframes batch equivalence as a multiscale evidential problem rather than a single similarity decision. The analysis distinguishes chemical comparability, process-associated change, exposure relevance, measured functional potency, and higher-order interpretation, while preserving boundaries between association and causation and between analytical compliance and functional equivalence. Evidence from multimodal fingerprinting, process-resolved chemical profiling, effect-oriented constituent weighting, metabolomics, and biological potency testing shows that chemical and functional information can be complementary and, in some settings, discordant. On this basis, the proposed model treats manufacturing drift as meaningful only when its interpretation is supported across the evidence levels relevant to the product's intended quality attributes, rather than whenever any detectable chemical change occurs. Conversely, high fingerprint similarity should not automatically neutralize concern when a function-relevant constituent, chemical domain, exposure determinant, or potency measure has shifted. The model is intended to support lifecycle reasoning, investigation prioritization, and evidence integration rather than to define universal equivalence limits. Its principal boundaries are assay dependence, incomplete constituent attribution, product-specific processing chemistry, confounding by nonmanufacturing sources of variation, and the current absence of prospectively validated cross-product decision thresholds.


How to cite this article
Vancouver
Kim D, Park J, Kang M, Jung H. Batch Equivalence Should Preserve Chemical Function, Not Only Fingerprint Similarity: A Multiscale Quality Model for Complex Herbal Preparations Across Manufacturing Drift. Spec J Pharmacogn Phytochem Biotechnol. 2026;6(1):61-70. https://doi.org/10.51847/cwOruQcShP
APA
Kim, D., Park, J., Kang, M., & Jung, H. (2026). Batch Equivalence Should Preserve Chemical Function, Not Only Fingerprint Similarity: A Multiscale Quality Model for Complex Herbal Preparations Across Manufacturing Drift. Specialty Journal of Pharmacognosy, Phytochemistry, and Biotechnology, 6(1), 61-70. https://doi.org/10.51847/cwOruQcShP
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