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盐酸阿霉素COA/25316-40-9
CERTIFICATE OF ANALYSIS
|
Product |
Doxorubicin Hydrochloride |
Batch Size |
0.9kg |
|
Batch No. |
20200811 |
Report Date |
2022-08-10 |
|
Manufacture Date |
2020-08-11 |
Retest time |
2022-08 |
|
Items |
Specification(USP31) |
Result |
|
|
Description |
Orange red powder |
Orange red powder |
|
|
Identification |
IR |
Conform to standard |
|
|
pH |
4.0～5.5 |
5.2 |
|
|
Water |
≤4.0% |
1.1% |
|
|
Residue on ignition |
≤0.1% |
0.06% |
|
|
Heavy metals |
≤0.001% |
＜0.001% |
|
|
Related substances(HPLC) |
Total impurities≤2.0% |
1.3% |
|
|
Assay(HPLC) |
98.0～102.0% |
99.8% |
|
|
Conclusion |
Conform with USP31 standard |
||
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