Customization: | Available |
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CAS No.: | 96946-42-8 |
Formula: | C65h82n2o18s2 |
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Item | Specification | Results |
Identification | A. HPLC | Complies |
B. I.R. | Complies | |
Appearance | White to off-white powder, odorless, hygroscopic. | Complies |
Assay | 97.0% ~102.0% | 99.7% |
Residue on ignition | NMT0.1% | 0.05% |
Organic impurities | cis-Quaternary acid : NMT 0.2% | 0.03% |
(R)-N-Methyllaudanosine: NMT 0.2% | ND | |
(R)-Laudanosine: NMT 0.6% | 0.05% | |
cis-Quaternary methyl ester: NMT 0.4% | ND | |
cis-Quaternary alcohol: NMT 0.5% | 0.06% | |
R-trans-R-trans-Atracurium: NMT 0.2% | ND | |
R-cis-R-trans-Atracurium: NMT 0.8% | 0.06% | |
trans-Monoquaternary compound: NMT 0.5% | ND | |
trans-Monoacrylate: NMT 0.5% | ND | |
cis-Monoquaternary compound: NMT 0.7% | ND | |
cis-cis-Triester analog: NMT 0.4% | ND | |
cis-Monoacrylate: NMT 1.0% | 0.05% | |
Any individual unspecified impurity: NMT 0.1% | 0.06% | |
Total impurities: NMT 3.0% |
0.34% |
|
Limit of methyl benzenesulfonate | NMT 10ppm | ND |
Optical Rotation | -60.0° ~ -54.0° | -57.8° |
PH | 5.0 ~ 6.5 | 5.5 |
Water Detemination | NMT 5.0% | 1.1% |
Conclusion | The test results conform to USP42. |
The End |