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2017-11-13 03:38
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Amoxicillin Sodium and Sulbactam Sodium Mixture Ratio 2:1 
Product Name: Amoxicillin Sodium and Sulbactam Sodium Mixture Ratio 2:1
Synonyms: Amoxicillin Sodium Sulbactam Sodium
Characteristics: White powder.
Assay and Potency: Please refer to the COA
Package: 6KG/TIN; 2TINS/CTN
Usage: Amoxicillin Sodium and Sulbactam Sodium 2:1 is the a good mix of 2 APIs.
COA—Amoxicillin Sodium and Sulbactam Sodium Mixture Ratio 2:1
Name of Product |
Amoxicillin Sodium and Sulbactam Sodium (2:1) |
|
Testing Item |
Standard |
Result |
Appearance |
White or almost white powder, or crystalline power. |
A white powder |
Identification |
The retention time of principal peak of the substance being examined is identical with that of amoxicillin and sulbactam CRS . Yields the flame reaction of Sodium salts |
Complies |
pH |
8.0 ~ 10.0 |
9.2 |
Appearance of Solution |
≤1 |
< 0.4 |
Color of solution |
≤5 |
< 1 |
Water |
≤ 4.0% |
0.4% |
Related Substance |
Any impurity ≤ 2.0% Total impurities ≤3.5% |
0.3% 0.7% |
Visible Particles |
Conforms |
Conforms |
Paticulate matter |
≥10 μm ≤ 6000 pc/g ≥25 μm ≤ 600 pc/g |
156 particle/g 0 particle/g |
Pyrogen |
Conforms |
Conforms |
Sterility |
Should meet the requirement |
Complies |
Assay |
Amoxicillin ≥54.0% Subactam ≥28.0% |
59.3% 31.3% |
