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盐酸表柔比星56390-09-1质检单
CERTIFICATE OF ANALYSIS
|
Product |
Epirubicin Hydrochloride |
Batch Size |
58g |
|
Batch No. |
20230507 |
Report Date |
2023-05-07 |
|
Manufacture Date |
2023-05-07 |
Expiration Date |
2026-05-06 |
|
Items |
Specification |
Result |
|
|
Description |
Orange red crystalline powder |
Orange red powder |
|
|
Identification |
IR |
Conform to standard |
|
|
PH |
4.0～5.5 |
5.1 |
|
|
Water |
≤4.0% |
1.0% |
|
|
Acetone |
≤15000ppm |
1200ppm |
|
|
Ethanol |
≤5000ppm |
3000ppm |
|
|
Methanol |
≤1000ppm |
100ppm |
|
|
Ethyl Acetate |
≤5000ppm |
None |
|
|
Methylene Chloride |
≤500ppm |
None |
|
|
Total Residual Solvents |
≤20000ppm |
4300ppm |
|
|
Impurity A |
0.03% |
||
|
Impurity C |
≤1.0% |
0.03% |
|
|
Any Other Impurity |
≤0.5% |
0.03% |
|
|
Total Impurities |
≤2.0% |
0.3% |
|
|
Residue on ignition |
≤0.1% |
0.05% |
|
|
Heavy metals |
≤0.001% |
＜0.001% |
|
|
Related substances(HPLC) |
Total impurities≤2.0% |
1.1% |
|
|
Assay(HPLC) |
97.0～102.0% |
99.7% |
|
|
Conclusion |
Conform with EP6.0 standard |
||
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