T/SDAHA 001-2023 Active Group standards

T/SDAHA 001-2023 Green Mold Extract for Veterinary Drugs and Preparations

T/SDAHA 001-2023

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 001-2023

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: 1. **Arginine Identification**: Follow the method specified in the *Chinese Pharmacopoeia*, Volume II, under the section "Identification of Banqing Granules" (2). In this section, the sampling amount is 0.5g, equivalent to 0.15g of the intermediate product, Banqing Extract. The determined sampling amount is 0.15 ± 0.015g. All other procedures follow the requirements of "Identification of Banqing Granules" (2). Three batches of extracts from pilot trials and three batches from different manufacturers were studied. In the chromatograms of the test samples, identical color spots were observed at the corresponding positions of the control samples. 2. **Dry Matter Loss**: Follow the method specified in the *Chinese Pharmacopoeia*, Volume II, Appendix 0831, "Determination of Dry Matter Loss". The results are shown in Table 1. 3. **Solubility**: Follow the method specified in the *Chinese Pharmacopoeia*, Volume II, Appendix 0106, "Solubility of Granules". The sampling amount is 10g, equivalent to 3g of the intermediate product, Banqing Extract. The determined sampling amount is 3 ± 0.3g. All other procedures follow the requirements of Appendix 0106. Three batches of extracts from pilot trials and three batches from different manufacturers were studied. All samples completely dissolved, with minor turbidity and no foreign substances such as burnt residue. 4. **Content Determination**: Due to the presence of multiple active ingredients in Daiqing leaves and Banlan root, primarily (R,S)-Jieshen, this item was developed to effectively control product quality. The total content of (R,S)-Jieshen, uridine, guanosine, and adenosine was used as a quality control indicator. The standard test method references and cites the chromatographic conditions specified in the *Chinese Pharmacopoeia*, Volume II, under the section "Quality Standards for Banlan Root Injection" and the sample preparation method specified in the *Chinese Pharmacopoeia*, Volume I, un