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TESTS |
SPECIFICATIONS |
RESULTS |
|
Description |
Colorless or light yellow oil |
Light yellow oil |
|
Identification |
A: IR B: The retention time of the major peak in the chromatogram of the sample corresponds to that of the standard solution, as obtained in the assay |
Complies |
|
Water |
NMT2.0% |
0.05% |
|
Optical rotation |
+31°~+38° |
+35.2° |
|
Residue on ignition |
NMT 0.5% |
0.05% |
|
Related substances (HPLC) |
Isopropyl Dipheny lphosphorylpentanoate |
NMT0.1% |
0.06% |
Related compound B |
NMT0.5% |
0.09% |
|
Related compound A |
NMT3.5% |
N.D |
|
Any unspecified impurity |
NMT0.1% |
0.06% |
|
Total other impurities |
NMT0.5% |
0.08% |
|
Related Compound E |
NMT0.2% |
0.02% |
|
Residue Solvent |
n-Hexane |
NMT0.029% |
Not detected |
Ethanol |
NMT0.5% |
0.15% |
|
Methanol |
NMT0.3% |
Not detected |
|
Isopropanol |
NMT0.5% |
Not detected |
|
Assay |
94.0%~102.0% |
99.77% |
|
Conclusion: The product complies as per above specification. |
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