Table 4.
The comparative analysis of quality standards for Scutellariae Radix in the standards of the mainstream pharmacopoeias, WHO and ISO.
| Items | ChP, 2015 | JP, 17th | KP, 11th | EP, 9.0 | USP-HMC | WHO monograph | ISO | |
|---|---|---|---|---|---|---|---|---|
| Definition | √ | √ | √ | √ | √ | √ | √ | |
| Description | √ | √ | √ | √ | √ | √ | √ | |
| Identification | Microscopic | √ | √ | √ | √ | √ | √ | √ |
| TLC | Reference crude drug; Baicalin; Baicalein; Wogonin | Reference crude drug; Baicalin | Reference crude drug | Baicalin; acteoside |
Reference crude drug; Baicalin; Baicalein | Baicalin | — | |
| Loss on drying | ≤10.0 % | ≤12.0 % | ≤15.0 % | ≤12.0 % | ≤12.0 % | ≤12.0 % | ≤15.0 % | |
| Total ash | ≤6.0 % | ≤5.0 % | ≤6.0 % | ≤6.0 % | ≤6.0 % | ≤6.0 % | ≤6.0 % | |
| Acid-insoluble Ash | — | — | ≤1.0 % | ≤2.0 % | ≤1.0 % | ≤1.0 % | — | |
| Ethanol-soluble extractives | ≥40.0 % | — | ≥24.0 % | — | ≥18.0 % | ≥15.0 % | ≥26.0 % | |
| Water-soluble extractives | — | — | — | — | ≥28.0 % | ≥40.0 % | — | |
| Assay | Baicalin: ≥9.0 % | Baicalin: ≥10.0 % | ≥10.0 % (total of Baicalin, baicalein and wogonin) | Baicalin: ≥9.0 % | ≥11.0 % (total of Baicalin and wogonin-7-O-glucuronide); ≥3.50 % (total of Baicalin and wogonin) |
Baicalin: ≥9.0 % | Baicalin: ≥8.0 % | |
| Heavy metals | — | √ | √ | √ | √ | √ | √ | |
| Pesticide residuals | — | — | √ | √ | √ | √ | √ | |
| Sulfur dioxide | ≤ 150 ppm | — | ≤ 30 ppm | — | — | — | — | |