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硫酸阿米卡星5:9,149022-22-0,COA
CERTIFICATE OF ANALYSIS
|
Product Name |
Amikacin Sulphate |
Batch No. |
230626 |
|
MFG. Date |
Jun.26,2023 |
Exp Date |
Jun.25,2025 |
|
Quantity |
200bou |
Packing |
5BOU/Tin;2Tin/Carton |
|
Standard |
USP35 |
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|
ITEMS |
SPECIFICATIONS |
RESULTS |
|
|
Description and solubility |
A white ,crystalline powder ,very soluble in water |
Complies |
|
|
Identification |
Positive reaction |
Complies |
|
|
Specific rotation |
+76o-+84o |
+79o |
|
|
Crystallinity |
Meets the requirements |
Complies |
|
|
PH |
2.0-4.0 |
3.6 |
|
|
Loss on drying |
Not more than 13.0% |
10.0% |
|
|
Residue on ignition |
Not more than 1.0% |
0.1% |
|
|
Assay |
Anhydrous potency content of C22H43N3O13 674-786ug/mg |
Anhydrous potency 718ug/mg |
|
|
Conclusion |
Conforming to USP35 |
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