ISO 22584 pdf download Traditional Chinese medicine — Angelica sinensis root
c)The root stock is known as “Angelica head” (or guitou). The main root is known as “Angelica body”
(or guishen).The branching root is known as “Angelica tails ” (or guiwei).The entire root is knownas”entire Angelica” (or quangu门.
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 andmostly twisted with a few rootlet scars.
fThe 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 cambiumring is yellowish brown.
h)The core of the root stock contains a pith and a cavity.
iThe 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 orbands with the same colour and positions corresponding to those of reference solutions.
The mass fraction of moisture should not be more than 15,0 %.5.5Total ash
The mass fraction of total ash should not be more than 7,0 %.5.6Acid-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 %.5.8Content of maker compound
The content of marker compound shall be determined. For example, ferulic acid shall be determinedtaking into account relevant national or regional pharmacopoeias, legislation and norms.
The mass fraction of ferulic acid(CoH1o04J 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 destinationcountry or region. If there is none, the limit value of a national or regional pharmacopoeia listed inISO 18664 shall be chosen.
5.10 Pesticide residues
The content of pesticide residues such as benzex, dichloro-diphenyl-trichloroethane (DDT) and quintozene shall be determined.
Sampling of Angelica sinensis root shall be carried out according to the World Health Organization’s Quality control methods for herbal materials, General advice on sampling.
7 Test methods
7.1? Macroscopic? identification
Samples not less than 500 g are taken from each batch randomly and observed with the naked eye.
7.2? TLC? identification
See Annex A for additional information.
7.3 Determination of moisture content
The testing method specified in ISO 20409 applies.
7.4 Determination of total ash
The testing method specified in ISO 1575 applies.
7.5 Determination of acid-insoluble ash
The testing method specified in ISO 1577 applies.
7.6 Determination of extractives
See Annex B for additional information.
7.7 Determination of ferulic acid
See Annex C for additional information.
7.8 Determination of heavy metal
The testing method specified in ISO 18664 applies.
7.9 Determination of pesticide residues
The testing methods specified in CODEX STAN 229 and CAC/MRL01 apply.
8 Test report
For each test method, the test report shall specify the following:
a) all information necessary for the complete identification of the sample;
b) a reference to this document, for example “determined in accordance with ISO 22584:2019″;
) the sampling method used;
d) the test method(s) used;
e) the test result(s) obtained;
f) all operational details not specified in this document, or regarded as optional, together with details of any incidents which may have influenced the test result(s);
g) any unusual features (anomalies) observed during the test;
h) the date of the test.
9 Packaging, storage and transportation
Packaging shall not transmit any odour or flavour to the product and shall not contain substances which may damage the product or constitute a health risk.
Angelica sinensis root should be preserved in a cool and dry place, and protected from light, pollution,moisture, moths and foreign substances during storage and long-distance delivery.
10 Marking and labelling
The method specified in ISO 21371 shall apply. The following items shall be marked or labelled on the packages:
a) product name and plant scientific name;
b) all quality features indicated in Clause 5;
c) country and province/state of the products;
d) date of production, batch number and expiry date of the products;
e) storage and transportation method;
f) items required by the regulatory body of the destination country.