| Customization: | Available |
|---|---|
| Powder: | Yes |
| Customized: | Customized |
|
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| Name of product | Amoxicillin and Clavulanate postassium(4:1) | ||
| Tests | Specifications | Results | |
| Characters | A white to slightly yellow powder .hygroscopic | A white powder , hygroscopic | |
| Identification | The retention time of the two major peak in the chromatogram of the Assay preparation corresponds to that exhibited in the chromatogram of the standard preparation. | Conforms | |
| Water | 9.0% ~12.0% | 10.2% | |
| PH | 3.5~7.5 | 5.3 | |
| Related substances | Any impurity ≤2.0% (calculated on the basis of amoxicillin peak areas in the chromatogram of reference solution) | 0.03% | |
| Total impurities ≤5.0% (calculated on the basis of amoxicillin peak areas in the chromatogram of reference solution) | 0.06% | ||
| Assay | Amoxicillin(C16 H19 N3 O5S)≥695 μg/mg, | Amoxicillin 772 μg/mg | |
| Clavulanic acid(C8 H9 NO5) ≥ 176μg/mg, | Clavulanic acid 193 μg/mg | ||
| The ratio of Amoxicillin to Clavulanic acid should be 3.6~ 4.4 | 4.0 | ||
| Name of product | Amoxicillin and Clavulanate postassium(7:1) | ||
| If you need 7:1, please contact our customer service | |||
| Name of product | Clavulanate Potassium-Microcrystalline Cellulose(1:1) | ||
| Tests | Specifications | Results | |
| Appearance | White or almost white powder, hygroscopic | Almost white powder, hygroscopic | |
| Identification | (l)HPLC: positive | Positive | |
| (2) Reaction (b) of potassium: positive | Positive | ||
| (3) Reaction of cellulose: positive | Positive | ||
| pH | 4.8 - 8.0 | 5.7 | |
| Polymeric impurities and other impurities absorbing at 278 nm | NMT 0.40 | 0.033 | |
| Water | NMT2.5% | 0.46% | |
| Related substances | Impurity E: NMT 1.0% | 0.014% | |
| Impurity G: NMT 1.0% | 0.0017% | ||
| Any other single impurity (major): NMT 0.10% | <0.05% | ||
| Total impurities: NMT 2.0% | 0.016% | ||
| Assay (HPLC) | 91.2% ~107.1% (as content of potassium clavulanate stated on the label) | 100.4% | |
| CLAV.ACID(as is)38.3%~45.0% | 42.1% | ||
| CLAV. POT. (as is)45.6%~53.5% | 50.2% | ||
| Conclusion | Conforms to the requirements of EP. | ||
| Name of product | Clavulanate Potassium-Silicon Dioxide(1:1) | |
| Tests | Specifications | Results |
| Appearance | A white or almost white powder, hygroscopic | A white powder, hygroscopic |
| Identification | (1) The principal peak in the chromatogram obtained with the test solution is similar in retention time to the principal peak in the chromatogram obtained with reference solution (a). | Conforms |
| (2)lt gives reaction (b) of potassium. | Conforms | |
| (3) It gives the reaction of silicates | Conforms | |
| PH | 4.8 ~8.0 | 5.1 |
| Absorbance | ≤0.40(278nm) | 0.064 |
| Related substances | Impurity E≤1.0% | 0.09% |
| Impurity G≤1.0% | <Reporting threshold limit0.05% | |
| Any other impurity ≤ 0.2% | <Reporting threshold limit0.05% | |
| Total impurities≤ 2.0% | 0.09% | |
| water | ≤2.5% | 0.53% |
| Residual Solvents | Aceton≤5000ppm | 48ppm |
| 1-butanol≤5000ppm | 909ppm | |
| Assay | It contains Potassium Clavulanate(C8H8KNO5)48.0%~53.5%,calculated on the anhydrous basis. | 49.9% |
| Conclusion | The results conform with EP and Enterprise standard. | |
Take amoxicillin and clavulanate exactly as prescribed by your doctor. Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.
Take the medicine every 12 hours, at the start of a meal to reduce stomach upset.
Do not crush or chew the extended-release tablet. Swallow the pill whole, or break the pill in half and take both halves one at a time. If you have trouble swallowing a whole or half pill, talk with your doctor about using another form of amoxicillin and clavulanate potassium.
The chewable tablet must be chewed before you swallow it.
Shake the liquid medicine well just before you measure a dose. Measure liquid medicine with the dosing syringe provided, or with a special dose-measuring spoon or medicine cup. If you do not have a dose-measuring device, ask your pharmacist for one.
Use this medicine for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Skipping doses may also increase your risk of further infection that is resistant to antibiotics. Amoxicillin and clavulanate potassium will not treat a viral infection such as the flu or a common cold.
This medicine can cause unusual results with certain lab tests for glucose (sugar) in the urine. Tell any doctor who treats you that you are using amoxicillin and clavulanate potassium.
Store the tablets at room temperature away from moisture and heat.
Store the liquid in the refrigerator. Throw away any unused liquid after 10 days.
|
Items |
Specifications |
Results |
|
Characteristic |
White or almost white |
Almost white powder
|
|
pH |
3.5 ~ 6.0 |
4.5 |
|
Crystallinity |
Conforms |
Conforms |
|
Water |
11.5% ~ 14.5% |
12.8% |
|
Assay (on the anhydrous basis) |
900~1050 μg/mg |
981μg/mg |
|
Tapped density |
≥0.70g/ml |
0.81g/ml |
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