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چکیده
The necessity of extending the graduated plan procedure of 1981 (see Notification mentioned above), which referred exclusively to medicinal products derived from Aristolochia, is resulting from the circumstance that AA I has been detected in three homeopathic mother tinctures of Asarum europaeum, in one mother tincture of Asarum canadense and in samples of the TCM drug Asari radix e rhizoma. The investigations were made in connection with the revision of the HAB monograph “Asarum europaeum“ and the elaboration of the Ph. Eur. monograph “Manchurian Wildginger Root and Rhizome“ (Asari radix e rhizoma). When investigated by the central laboratory of German pharmacists (Zentrallaboratoriums Deutscher Apotheker) in 2007, the TCM drugs Asari radix and Asari radix e rhizoma were detected to contain AA concentrations of 5.1 μg/g and 2.7 μg/g (DAC sample 7, limit of quantitation: 6 ppm).
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