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阿莫西林克拉维酸钾颗粒.doc(阿莫西林克拉维酸钾颗粒.doc)
阿莫西林克拉维酸钾颗粒.doc(阿莫西林克拉维酸钾颗粒.doc)
New varieties
Amoxicillin and Clavulanate Potassium Granules
Amoxilin Kelaweisuanjia Keli
Amoxicillin and Clavulanate Potassium Granules
This product is a mixture of amoxicillin and amoxicillin / clavulanate potassium (C16H19N3O5S) and clavulanic acid (C8H9NO5) labeled amount ratio of 2: 1 or 4: 1 or 7: 1], containing amoxicillin (C16H19N3O5S) should be labeled amount of 90% ~ 110%, containing clavulanic acid (C8H9NO5) should be the labeled amount from 90% to 120%.
[properties] this product is white to light yellow particles or suspended particles or fine particles; aromatic, sweet.
[identification] [1] in the determination of the chromatogram recorded under, the retention time of the sample solution should be two peaks were consistent with the retention time of standard solution corresponding to the two peak.
[2] (1) of the product of 1 bags, when necessary, porphyrized, diluted alcohol, shake for 2 ~ 3 minutes, to form a solution, each 1ml contains about 25mg of amoxicillin static, the supernatant was 1ml with hydroxylamine hydrochloride solution 1ml, shaking, and acidic ammonium ferric sulfate solution 1 drops, shake well. Colour is orange red, deep orange red or pale orange red.
(2) and (1) under the 1ml supernatant, adding alkaline copper tartrate solution 0.5ml, and about 30 seconds after the color of the solution should be a deep red color.
(3) take this product 1 packets, when necessary, porphyrized, plus pH7.0 phosphate buffer solution (if necessary, the ice bath 10~15 minutes of ultrasonic solubilization) to produce a solution, each 1ml contains about 5mg of amoxicillin static, filtration, the successive filtrate as the test solution; the control of amoxicillin and clavulanic acid control the amount, add pH7.0 phosphate buffer solution (when necessary ETUS 10 ~ 15 minutes, the clavulanic acid to be added after ultrasound) made of 5mg acid solution containing amoxicillin and clavulanic per 1ml, as the reference solution; ano
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