ABSTRACT
Substitute reference substance method is an effective approach for quality control of multiple components in accordance with the characteristics of traditional Chinese medicines. The purpose of the guideline is to guide the establishment of substitute reference substance method, prove the conformance of the method to the requirements for testing, and standardize the study method and its application in national drug standards. The topics of the guideline include the definition and classification of substitute reference substance method, the principles and approaches of quantitative analysis, the identification and confirmation of chromatographic peaks, and technical requirements. When substitute reference substance method is used for fingerprint identification or multiple components assay in traditional Chinese medicines, the analytical method can be validated following the guideline.