| Product name |
Escitalopram oxalate |
| CAS No. |
219861-08-2 |
Outer Packing |
1kg/bag |
| Production date |
Feb 2nd 2018 |
Shelf life |
Feb 1st 2020 |
| Standard adopted |
USP37 |
| Item |
Requirements |
Test Results |
| Appearance |
White to slightly yellow powder |
White powder |
| Identifications |
A:IR: Conforms to spectrum of Escitalopram Oxalate RS |
Conforms to spectrum of Escitalopram
Oxalate RS |
|
B:The retention time of the major peak of sample
solution corresponds to that of the standard solution,
as obtained Assay |
The retention time of the major peak of
sample solution corresponds to that of the
standard solution, as obtained Assay |
| Water |
≤1.0% |
0.5% |
| Residue on ignition |
≤0.10% |
0.04% |
| Enantiomeric purity |
≤3.0% |
0.3% |
| Organic impurities |
5-Dimethylaminobutyryl citalopram : ≤0.20% |
Undetected |
|
Citalopram related compound A: ≤0.10% |
Undetected |
|
Citalopram related compound B:≤0.10% |
Undetected |
|
Citalopram related compound C:≤0.10% |
0.05% |
|
Citalopram related compound D:≤0.10% |
Undetected |
|
Citalopram related compound E:≤0.10% |
0.03% |
|
Individual unspecific impurity: ≤0.10% |
RRT=1.09:0.07%; RRT=1.17:0.01%;
RRT=1.22:0.02% |
|
Total impurities: ≤0.50% |
0.18% |
| Residual solvents |
Acetone: ≤0.50% |
Undetected |
|
Toluene : ≤0.089% |
Undetected |
|
Ethanol: ≤0.5% |
0.02% |
|
Acetic acid ≤0.5% |
Undetected |
|
Triethylamine: ≤0.10% |
Undetected |
|
Isopropanol: ≤0.5% |
Undetected |
|
Dichloromethane ≤0.06 |
Undetected |
|
2-Methylterahydrofuran: ≤0.0002% |
Undetected |
|
Benzene: ≤0.0002% |
Undetected |
| Heavy metals |
≤0.002% |
complies |
| Assay |
98.0~102.0%(Calculated on anhydrous basis) |
100.3% |
| Conclusion |
The above material complies with USP37 |
