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阿莫西林鈉/34642-77-8/質量信息COA
CERTIFICATE OF ANALYSIS
|
Product Name |
Ampicillin sodium |
Batch No. |
22101207 |
|
Quantity |
300kg |
MFG. Date |
2022.10.12 |
|
Exp. Date |
2024.09 |
Specification |
BP2010 |
|
ITEMS |
SPECIFICATIONS |
RESULTS |
|
|
Characters |
A White or almost white powder
|
A white powder |
|
|
Identification |
Conforms |
Conforms |
|
|
Appearance of solution |
≤2 |
0.25 |
|
|
Absorbance(430nm) |
≤0.15 |
0.005 |
|
|
PH |
8.0~10.0 |
8.92 |
|
|
Specific optical rotation |
+258°~287° |
+281.7° |
|
|
Ampicillin dimer |
≤4.5% |
3.16 |
|
|
Other maximum individual impurity |
≤2.0% |
0.35% |
|
|
2-Ethylhexanoic aicd |
≤0.8% |
N.D. |
|
|
Methylene chloride |
≤0.2 |
0.03% |
|
|
Heavy metals |
≤20ppm |
Conforms |
|
|
Water |
≤2.0% |
0.78% |
|
|
Sterility |
Conforms |
Conforms |
|
|
Bacteria endotoxins |
Conforms |
Conforms |
|
|
Assay (C16H18N3NaO4S) |
89.0%~102.0% |
96.06% |
|
|
Conclusion |
COMPLIES WITH BP2010 |
||
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