This document specifies general requirements within a quality control framework for raw materials and finished products used in and as traditional Chinese medicine (TCM) and derivative forms, and the comparison between the starting materials and the finished products, if necessary.

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    • Standard
      22 pages
      English language
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    • Draft
      23 pages
      English language

This document specifies requirements for identity testing within a quality control framework for raw materials and finished products used in and as traditional Chinese medicine (TCM) and derivative forms. It is applicable to natural products used in TCM, including starting materials and finished products of herbal origin.

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    • Standard
      17 pages
      English language
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    • Draft
      17 pages
      English language

This document specifies the determination method of sulfur dioxide in natural products used in traditional Chinese medicine, which includes the requirements of the device, chemicals, operational procedures and formula. It is applicable to natural products of traditional Chinese medicine, including Chinese materia medica (whole medicinal materials) and decoction pieces derived from plants or animals. It is not applicable to minerals used in traditional Chinese medicine.

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    • Standard
      13 pages
      English language
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    • Draft
      13 pages
      English language

This document specifies the methods for the determination of aflatoxins (AFB1, AFB2, AFG1, AFG2) in natural products using LC-FLD. It is applicable to the analysis of aflatoxins in raw materials and manufactured products, including decoction pieces derived from plants and animals.

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    • Standard
      13 pages
      English language
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    • Draft
      13 pages
      English language

This document specifies the general storage requirements for raw materials and decoction pieces. It is applicable to the storage of raw materials and decoction pieces used in traditional Chinese medicine.

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    • Standard
      51 pages
      English language
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    • Draft
      51 pages
      English language

This document specifies methods for the determination of the selected Aconitum alkaloids, including aconitine, mesaconitine, hypaconitine, benzoylaconine, benzoylmesaconine, benzoylhypaconine, yunaconitine, deacetyl-yunaconitine and crassicauline A.

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    • Standard
      15 pages
      English language
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    • Draft
      16 pages
      English language

This document specifies the method of determination of pesticide residues in natural products used in traditional Chinese medicine (TCM) by gas chromatography (GC), including Chinese materia medica (whole medicinal materials) and decoction pieces derived from plants.

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    • Standard
      14 pages
      English language
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    • Draft
      14 pages
      English language

This document specifies a method using photostimulated luminescence (PSL) to detect the radiation status of natural products. It can be used to identify whether raw and traditionally processed Chinese medicinal materials and solid forms of manufactured product made from these materials have been irradiated by ionizing radiation (gamma, X-ray or beam). It is not applicable for use in testing liquid dosage forms or partially solid extracted dosage forms that do not contain directly crushed medicin...view more

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    • Standard
      5 pages
      English language
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    • Draft
      5 pages
      English language

ISO 21371:2018 specifies general requirements for the labelling of products intended for oral or topical use in and as traditional Chinese medicine (TCM). ISO 21371:2018 is applicable to all finished manufactured products including packaged herbs used in and as TCM. This document includes the essential and informative elements for labelling of products to assist in the choice and safe use of these products by consumers and practitioners. NOTE A list of TCM labelling requirements of the WHO and v...view more

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    • Standard
      6 pages
      English language