Amoxicillin Sodium and Clavulanate Potassium Mixture 
Product Name: Amoxicillin Sodium and Clavulanate Potassium Mixture Ratio 5:1
Synonyms: Amoxicillin Sodium Clavulanate Potassium
Characteristics: White or off-white powder
Assay and Potency:
Amoxicillin (C16H19N3O5S) ≥693μg/mg
Clavulanic Acid(C8H9NO5) ≥139μg/mg
Package: 10Kg/Tin/Ctn
COA—Amoxicillin Sodium and Clavulanate Potassium Mixture 5:1
Name of Product |
Amoxicillin Sodium and Clavulanate Potassium (5:1) |
|
Testing Item |
Standard |
Result |
Appearance |
White or off-white powder |
Complies |
Identification |
(HPLC)Same retention time with the standard reference |
Complies |
PH |
8.0 ~ 10.0 |
8.9 |
Clarity of Solution |
≤ reference suspension 1 |
<reference suspension 0.5 |
Color of solution |
≤ reference suspension Y6 or YG6 |
<reference suspension Y1 |
Moisture |
≤ 1.5% |
0.49% |
Related Substance |
Any impurity ≤ 2.0% Total impurities ≤ 5.0% |
0.43% 0.69% |
Bacterial Endotoxins |
< 0.25EU/mg |
< 0.25EU/mg |
Sterility |
Should meet the requirement |
Complies |
Visible Particles |
Should meet the requirement |
Complies |
Paticulate matter |
NLT 10 μm NMT 2000 pc/g NLT 25 μm NMT 200 pc/g |
573 pc/g 23 pc/g |
Assay |
Amoxicillin (C16H19N3O5S) ≥693μg/mg Clavulanic Acid(C8H9NO5) ≥139μg/mg |
753 μg/mg 150 μg/mg |