ISO 21316:2019 pdf free

ISO 21316:2019 pdf free.Traditional Chinese medicine – Isatis indigotica root
The identification of marker compound, such as (R,S)-goitrin with thin-layer chromatogram (TLC),shall present spots or brands obtained from the test and reference solutions in the same position with the same colour.
Sampling of Isatis indigotica root shall be in accordance with the World Health Organization’s Quality control methods for herbal materials: General advice on sampling.
a) From a batch of five containers or packaging units, take a sample from each one.
b) From a batch of 6 to 50 units, take a sample from five.
c) From a batch of over 50 units, sample 10 %, rounding up the number of units to the nearest multiple of 10. For example, a batch of 51 units would be sampled as for 60, i.e. take samples from six packages.
d) From each container or package selected, take three original samples from the top, middle and bottom of the container or package. The three original samples should then be combined into a pooled sample that should be mixed carefully.
e) The average sample is obtained by quartering. From the pooled sample, adequately mix into an even and square-shaped heap, and divide it diagonally into four equal parts. Take two diagonally opposite parts and mix carefully.
f) Repeat the process as necessary until the required quantity, to within±10 %, is obtained.
g) Using the same quartering procedure, divide the average sample into four final samples, takingcare that each portion is representative of the bulk material.
h) The final samples are tested for the measurement and analyses specified in Table 1.
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. The packaging shall be strong enough to withstand normal handling and transportation.
The product drug shall be sealed and stored in a dry, shady and cool place.The Isatis indigotica root shall be protected from light, moisture, pollution and entry of foreign substances during long-distance delivery.ISO 21316 pdf free download.