Reference Standards Management¶
1. Standard Classification¶
| Standard Type | Source | Usage |
|---|---|---|
| Primary Reference | Commercially sourced, fully characterized | Calibration of working standards |
| Working Standard | Qualified against primary standard | Routine analysis |
2. Qualification Criteria¶
| Parameter | Primary Standard | Working Standard |
|---|---|---|
| Purity (HPLC) | ≥99.0% | ≥98.0% |
| Identity (MS) | Confirmed within ±0.5 Da | Confirmed within ±0.5 Da |
| Water Content | ≤1.0% | ≤2.0% |
| Certificate of Analysis | Required | Required |
3. Storage and Retest¶
| Condition | Storage | Retest Interval |
|---|---|---|
| −20 °C | Sealed, desiccated | 12 months |
| 4 °C | Sealed, desiccated | 6 months |
| Room temperature | Sealed, desiccated | 3 months |