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质量报告单
|
Product name |
sirolimus |
Batch no |
20220601 |
|
Mfg.date |
June 03.2022 |
Exp.date |
June 05.2024 |
|
Cas no |
53123-88-9 |
Quantity |
200gm |
|
Item |
specification |
Result |
|
|
appearance |
White or off-white crystalline powder |
White crystalline |
|
|
Identification(IR) |
positive |
positive |
|
|
Specific optical rotation |
-157o～+147o |
-150o |
|
|
water |
≤0.5% |
0.2% |
|
|
Residue on ignition |
≤0.2% |
0.1% |
|
|
Heavy metals |
≤0.002% |
conforms |
|
|
Impurity A |
≤1.0% |
0.4% |
|
|
Impurity B |
≤0.5% |
0.3% |
|
|
Impurity D |
≤0.5% |
Not detected |
|
|
Individual impurity |
≤0.1% |
Not detected |
|
|
Total impurtities(except isomer) |
≤0.1% |
0.8% |
|
|
isomer |
≤3.5% |
2% |
|
|
Assay |
≥98.0% |
99.1% |
|
|
conclusion |
Conforms to in-house standard |
||
