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Items of Analysis | Standard of Analysis | Test Results |
Appearance | White to off-white powder | Conforms |
Single impurity | ≤0.2% | 0.03% |
Total impurities | ≤0.5% | 0.14% |
Lossing on drying | ≤1.0% | 0.15% |
Residue on ignition | ≤0.1% | 0.06% |
Heavy metals | ≤20ppm | Conforms |
Assay | 99.0%-101.0% | 99.5% |
Conclusion | Conform to the enterprise standard |
Market News:Earlier this month, the drugmaker lifted a voluntary EU marketing hold on Zynteglo for beta thalassemia, after a patient death in one of the drugmaker’s other products, LentiGlobin, halted clinical studies. Amino-phenyl-acetic acid (1S,2R,4S)-1,7,7-trimethyl-bicyclo[2.2.1]hept-2-yl ester manufacturer.Bluebird determined that death was highly unlikely to have been caused by the delivery virus used in both Zynteglo and LentiGlobin. 1-carbamoyl-3-(2-phenylethyl)urea supplier.Lonza is investing CHF 20 million in GMP laboratories and mid-scale manufacturing assets at its API manufacturing center in Nansha, China. The investment will allow Lonza to provide a smoother transition from small-scale to large-scale manufacturing for customers. 1H-Pyrrole, 1-butyl-2,4-diethyl-3-propyl- producer.
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