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Batch Characteristics of all Batches Manufactured from 2003 to 2005 Used for Validation
| Batch Characteristic | Range |
|---|---|
| No. of products | 7 |
| No. of batches | 97 |
| Batch size | 75–800 vials |
| Dissolution vehicle | DMSO, WfI, TBA/WfIa |
| API concentrationb | 0.5–150 mg/ml |
| Filling volume | 1–40 ml |
aDMSO dimethyl sulfoxide, WfI water for injection, TBA/WfI 40% v/v TBA in WfI.
bConcentration of API in the formulation solution.
