T/SDAHA 002-2023 Active Group standards

T/SDAHA 002-2023 Indigo root extract for use in veterinary drug preparations

T/SDAHA 002-2023

Publish Date: 2023-09-26 Implement Date: 2023-10-25 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

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Basic Information

Standard Code: T/SDAHA 002-2023

Standard Type: Group standards

Standard Status: Active

is_force_gb: no

CCS Name: -

ICS Name: Veterinary medicine

Publish Date: 2023-09-26

Implement Date: 2023-10-25

Scope

Main technical content: **Technical Indicator 1**: For the identification of L-proline, arginine, and leucine, follow the "Identification" section of the *Chinese Pharmacopoeia (Second Edition)* for Radix Isatidis Injection. The sampling amount in this section is 2ml, equivalent to 0.1g of the intermediate product Radix Isatidis Extract. The determined sampling amount is 0.1±0.01g. Other procedures follow the "Identification" section for Radix Isatidis Injection. Three batches of pilot-scale extracts and three batches from different manufacturers were studied. In the chromatograms of the samples, identical color spots were observed at the corresponding positions of the reference sample chromatograms. **Drying Loss**: Follow the "Determination of Drying Loss" method in Appendix 0831 of the *Chinese Pharmacopoeia (Second Edition)*. The results are shown in Table 1. Table 1: Determination of Drying Loss for Radix Isatidis Extract **Manufacturer** **Batch No.** **Drying Loss (%)** Self-made (main producing area raw materials) 2303150 13.42 Self-made (main producing area raw materials) 2303160 14.83 Self-made (non-main producing area raw materials) 2303170 14.51 Manufacturer AA 16.63 Manufacturer BB 18.59 Manufacturer CC 17.43 The results show that the drying loss of Radix Isatidis Extract is mostly below 8.0%. To better control product quality, the drying loss limit is set to ≤8.0%. **Impurities**: 3.1 Protein: Follow the "Protein" section of the *Chinese Pharmacopoeia (Second Edition)* for Injection-Related Impurities Inspection, with a sampling amount of 1ml equivalent to 0.05g of the intermediate product Radix Isatidis Extract. Other procedures follow the "Protein" section of the *Chinese Pharmacopoeia (Second Edition)*. Three batches of pilot-scale extracts and three batches from different manufacturers were studied, and no turbidity was observed. 3.2 Tannins: Follow the "Tannins" section of the *Chinese P