Review and comparison of acceptance criteria for Senna and its preparations according to BP (2015 and 2020) and USP-NF (39-34 and 43-38)

Abstract

Background: Quality and quantity assurance of herbs are global concerns. This study aimed to classify and compare the monographs and test procedures of Senna parts and preparations according to two editions of BP and USP-NF. The monographs and specifications were compared to suggest an applicable approach to extract relevant data. Methods: BP 2015 and 2020, USP-NF 39-34 and 43-38, as well as scientific databases were used for literature review. Results: the results of this study were classified in 3 tables; table 1 classified specifications of herbal monographs in pharmacopeias. Table 2 classified various identification tests, measurement methods, and standard phytochemicals for quantitative assays. Table 3 outlined and categorized related physicochemical and contamination tests for quality assurance according to two editions of BP and USP-NF. In both editions of USP-NF, only sennosides powder and tablets were required to be analyzed for heavy metals. Hence, microbial contamination tests were merely included for leaves and pods of Senna. In both editions of BP, assessment of microbial contamination was merely included in the monograph of dry extract of Senna, not for the rest of monographs. Comparing two editions of BP indicated that in BP 2020, LC and HPTLC methods were added to assure the quality of pods and leaflets of Senna species. Conclusion: preparation of tabular data will assist analysts to extract desired information and guidelines to prepare licensed herbal products. This approach could be applicable to select relevant tests according to the facilities and equipment of laboratories.