Erlotinib intermediates manufacturer
| Inspect Item | Specification | Results |
| Appearance | White crystalline powder or granules | Conform |
| Identification | Passes Test A,B,C | Conform |
| Assay % | 98.0~100.5 | 99.09 |
| Specific Rtation [a]25D | +95.5°~+98.0° | 96.30° |
| PH Value | 5.5~8.0 | 7.4 |
| Lead mg/kg | 5 max | 1.0 |
| Loss on drying % | 0.25 max | 0.11 |
| Oxalate | Passes Test | Conform |
| Conclusion |
Conform Basis of Analysis:FCC(VI) Standard of USA and Client’s Requirements |
|
