ISO 22584:2019 pdf – Traditional Chinese medicine — Angelica sinensis root.
1 Scope This document specifies minimum requirements and test methods for Angelica sinensis root that is derived from Angelica sinensis (Oliv.) Diels. It is applicable to Angelica sinensis root that is sold and used as a natural medicine in international trade, including Chinese materia medica (whole medicinal materials) and decoction pieces derived from this plant. 2 Normative references The following documents are referred to in the text in such a way that some or all of their content constitutes requirements of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. ISO 1575, Tea — Determination of total ash ISO 1577, Tea — Determination of acid-insoluble ash ISO 18664, Traditional Chinese Medicine — Determination of heavy metals in herbal medicines used in Traditional Chinese Medicine ISO 20409, Traditional Chinese medicine — Panax notoginseng root and rhizome ISO 21371, Traditional Chinese medicine — Labelling requirements of products intended for oral or topical use CAC/MRL01 Maximum Residue Limits for Pesticides in Foods CODEX STAN 229, Analysis of pesticide residues: Recommended methods World Health Organization 2011, Quality control methods for herbal materials, General advice on sampling 3? Terms? and? definitions For the purposes of this document, the following terms and definitions apply. ISO and IEC maintain terminological databases for use in standardization at the following addresses: — ISO Online browsing platform: available at https:// www .iso .org/ obp — IEC Electropedia: available at http:// www .electropedia .org/ 3.1 root main underground part of a plant that can branch 3.2 root stock top part of the dried main root (3.1), which is closest to the stem 3.3 total ash residue obtained after incineration at 525 °C ± 25 °C
d) The root stock is 15 mm to 40 mm in diameter, annulated with obtuse and rounded apex or with purple or yellowish green remains of stems and leaf sheaths. e) The main root is thick and short with numerous branching roots in the lower part. The upper portion of the branching root is thick, while the lower portion of the branching root is thin and mostly twisted with a few rootlet scars. f) The texture is flexible. g) The fracture is yellowish white or pale yellowish brown with numerous brown-spotted secretory cavities in the thick bark. The wood is paler in colour than the bark with radial lines. The cambium ring is yellowish brown. h) The core of the root stock contains a pith and a cavity. i) The odour is strongly aromatic; the taste is sweet, pungent and slightly bitter. 5.3? Identification? of? Angelica sinensis root The identification of Angelica sinensis root by a thin-layer chromatogram (TLC) shall present spots or bands with the same colour and positions corresponding to those of reference solutions. 5.4 Moisture The mass fraction of moisture should not be more than 15,0 %. 5.5 Total ash The mass fraction of total ash should not be more than 7,0 %. 5.6 Acid-insoluble ash The mass fraction of acid-insoluble ash should not be more than 2,0 %. 5.7 Extractives The mass fraction of 70 % ethanol-soluble extractives should not be less than 40,0 %. 5.8 Content of maker compound The content of marker compound shall be determined. For example, ferulic acid shall be determined taking into account relevant national or regional pharmacopoeias, legislation and norms. The mass fraction of ferulic acid (C 10 H 10 O 4 ) should not be less than 0,050 %. 5.9 Heavy metal The content of heavy metals such as arsenic, mercury, lead and cadmium shall be determined. The limit value should take into account the requirements of the regulatory bodies of the destination country or region. If there is none, the limit value of a national or regional pharmacopoeia listed in ISO 18664 shall be chosen.