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% |
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