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TC-07


               Withania somnifera (Ashwagandha): Product quality and implications for

               consumer safety


                                                                                 1
                                                           1,2
                                                                                                  1
                                    1,2
               Elmira  Kartbayeva,   Gulnaz  Seitimova,   Proma  Khondkar,   Abeer  Ahmed,   Denia
                                                1
                            1
               Mae Billoso,  Mudassir Ahmed,  Anthony Booker*      ,#,1,3

                1
                 University of Westminster, 115 New Cavendish Street, London, UK
                2
                 Al-Farabi Kazakh National university, al-Farabi Avenue 71, Almaty, Kazakhstan
                3
                 UCL School of Pharmacy, 29-39 Brunswick Square, London, UK
                * Email: a.booker@westminster.ac.uk

               Abstract
                  Recent reports of liver toxicity associated with Withania somnifera (L.) Dunal have led to
               regulatory restrictions and bans in several countries. Hepatotoxic reactions may be intrinsic,
               idiosyncratic,  or  due  to  adulteration,  with  known  contaminants  including  aflatoxins,
               pyrrolizidine  alkaloids,  heavy  metals,  incorrect  species,  or  inappropriate  plant  parts.
               Traditionally, W. somnifera is consumed as an aqueous root extract, and deviations in extraction
               methods may alter its established safety profile. This study aimed to investigate the quality and
               consistency of  commercially  available  W. somnifera  products.  Samples  were sourced from
               internet-based retailers and subjected to comprehensive quality assessment, including HPTLC,
               NIR, and HPLC techniques. Physical parameters such as tablet hardness, disintegration and
               friability  were also  measured, alongside evaluations  for label  compliance. Results revealed
               substantial  variability  in  both  the  composition  and  concentration  of  key  metabolites,  with
               several products containing minimal levels of important withanolides. Over 90% of the samples
               failed to meet national labelling standards, with many making unauthorized therapeutic claims.
               No evidence of leaf contamination was found in products labelled as root extracts. However,
               the  use  of  non-traditional  extraction  methods  significantly  altered  the  chemical  profiles
               compared to the traditional aqueous extract. These findings underscore the inconsistent quality
               of W. somnifera products available online and emphasise the need for stricter quality control
               and regulatory governance.

               Keywords: Ashwagandha; Withania somnifera; Quality; Liver toxicity
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