Table 2 Specifications for IRDye800CW-nimotuzumab
From: Pre-clinical study of IRDye800CW-nimotuzumab formulation, stability, pharmacokinetics, and safety
Test parameter | Method | Acceptance Limits |
|---|---|---|
Visual appearance | Visual inspection | Clear, green solution, free from visible particulates |
pH | pH meter | 6.5–7.5 |
Labelling ratio (Dye:Protein) | UV | 0.7–2.0 |
Strength (mg/mL) | UV | 10 (±20%) |
Volume (mL) | Weight | 5 (±10%) |
Functional assay (Binding to cells) | Flow cytometry | KD,sample/KD,ref × 100% < = 200% > = 50% |
Identity and purity (protein) | Micro-capillary electrophoresis | 150 kDa (±10%) Peak > = 95% |
Purity (fluorescence) | SDS-PAGE | > = 90% |
Bacterial endotoxin | USP < 85> | < 16 EU/mL |
Sterility | USP < 71> | No growth |