How do you ensure batch-to-batch consistency?
Consistency is guaranteed through fixed Dao-di fruit sourcing, standardized extraction parameters, and dual HPLC/GC-MS fingerprint release with tight tolerance bands.
Consistency Controls
| Control | Detail |
|---|---|
| Raw material | Fixed GAP bases in Changbai Mountain; graded fruit specs (ripeness, moisture ≤ 16.0%, impurity ≤ 1%) |
| Extraction SOP | Fixed SFE-CO2 parameters (30 MPa / 50°C; 5 MPa / 40°C) or distillation parameters per grade |
| Release testing | HPLC (lignans) + GC-MS (fatty acids) dual fingerprint per batch |
| Tolerance | Key active ± 10–15% of target; density/RI within COA range |
| Blending | Cross-blending of production lots to normalize minor natural variation |
| Storage | Sealed, inert-atmosphere bulk storage to prevent drift |
- Each COA states the batch fingerprint vs. the reference fingerprint for traceability
- Typical drift between batches: total lignans within ±10% of the reference value
- We keep retained samples of every batch for 3 years for dispute resolution
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This article was published on 2026-09-07, and last updated on 2026-09-07. The article will be continuously updated.
