| Thresholds | Specification Limit for Drug Substance in % | Specification Limit for Drug Product in % |
|---|---|---|
| Reporting Threshold | - | - |
| Note: LOQ (Limit of Quantification) should ideally be lower than or equal to the reporting threshold. | ||
| Identification Threshold | - | - |
| Note: Unknown impurities must be below or equal to the identification threshold. | ||
| Qualification Threshold | - | - |
| Note: Qualification Threshold is typically the limit for known impurities; above this, safety qualification is required. | ||