Molnupiravir Uridine-5'-methylpropanoate-4-oxime EIDD-2801
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ITEMS |
SPECIFICATION |
RESULTS |
Appearance |
White to off-white powder |
White powder |
Identification |
IR:Sample spectrum corresponds to that of standard spectrum. |
Complies |
HPLC: The retention time of main peak of test product is consistent with that of standard |
Complies |
|
Loss on drying |
NMT 1.0% |
0.06% |
Water content |
NMT 0.5% (By KF) |
0.1% |
Optical Rotation |
Between -7.5° ~ -9.5° (C=0.5,methanol) |
-8.7° |
Heavy Metal |
NMT 10ppm |
Complies |
Related substance |
20H01 NMT 0.1% |
ND |
20H02 NMT 0.1% |
ND |
|
20H04 NMT 0.1% |
ND |
|
20HIb NMT 0.3% |
0.02% |
|
20H21 NMT 0.1% |
ND |
|
Any individual impurity ≤0.1% |
0.02% |
|
Total impurities ≤0.5% |
0.1% |
|
Residual solvent |
Ethanol ≤ 5000ppm |
ND |
Methylene dichloride ≤ 600ppm |
ND |
|
Acetonitrile ≤ 410ppm |
ND |
|
N-Heptane ≤ 5000ppm |
ND |
|
Acetone ≤5000ppm |
ND |
|
Isopropyl acetate ≤5000ppm |
ND |
|
Ethyl acetate ≤5000ppm |
ND |
|
Isopropanol ≤5000ppm |
40ppm |
|
Purity |
NLT 99.5% (230nm) |
99.9% |
Assay (HPLC) |
98.0% ~102.0% |
99.6% |
Conclusion: The test results are conformed to the in-house specification |
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