 |
| Menge: | |
|---|---|
DY159020
179324-69-7
C19H25BN4O4
Bortezomib
| Index name | Specification |
| Description | White or off-white crystalline powder |
| Identification by NMR | THE NMR spectrum of the sample should be the same as that of reference material |
| Residue on Ignition | NMT 0.1% |
| Heavy Metal | NMT 20ppm |
| Related substances | Total impurities: NMT 1.0% Impurity A: NMT 0.3% Impurity B: NMT 0.3% Impurity C: NMT 0.3% other impurity: NMT0.1% |
| methanol | Should be conforms ICH Q3C class 2 NMT 3000ppm |
| Methylene dichloride | Should be conforms ICH Q3C class 2 NMT 600ppm |
| Loss on drying | NMT 0.5% |
| Assay | NLT 98.5-NMT101.5% |
| Index name | Specification |
| Description | White or off-white crystalline powder |
| Identification by NMR | THE NMR spectrum of the sample should be the same as that of reference material |
| Residue on Ignition | NMT 0.1% |
| Heavy Metal | NMT 20ppm |
| Related substances | Total impurities: NMT 1.0% Impurity A: NMT 0.3% Impurity B: NMT 0.3% Impurity C: NMT 0.3% other impurity: NMT0.1% |
| methanol | Should be conforms ICH Q3C class 2 NMT 3000ppm |
| Methylene dichloride | Should be conforms ICH Q3C class 2 NMT 600ppm |
| Loss on drying | NMT 0.5% |
| Assay | NLT 98.5-NMT101.5% |