Table 7 The lower limits of process CQAs and probability requirements for compliance.
Process CQAs | Minimum | Acceptable probability of design space |
|---|---|---|
Dry matter removal (%) | 40 |  ≥ 90% |
Purity of Astragaloside IV (μg/g) | 800 | |
Purity of Astragaloside II (μg/g) | 700 | |
Purity of CG (μg/g) | 1800 | |
Purity of PG (μg/g) | 600 | |
Purity of IFG (μg/g) | 600 |
