Molecular Formula | C16H20N3NaO5S |
Molar Mass | 389.4 |
Melting Point | 130℃ |
Boling Point | 743℃ |
Flash Point | >110°(230°F) |
Water Solubility | Soluble in water. |
Solubility | DMSO 78 mg/mL Water 78 mg/mL Ethanol <1 mg/mL |
Appearance | Liquid |
Storage Condition | under inert gas (nitrogen or Argon) at 2–8 °C |
Sensitive | Easily absorbing moisture |
Use | This product is for scientific research only and shall not be used for other purposes. |
RTECS | XH8300000 |
Raw Materials | Amoxicillin |
(2S,5R,6R)-3, 3-dimethyl-6-[(R)-( -)-2-amino -2-(4-hydroxyphenyl) acetamido]-7-oxo-4-thia-1-azabicyclo [3.2.0] Sodium heptane-2-carboxylate. Calculated as anhydrous, containing amoxicillin (according to C16H19N305S) shall not be less than 80.0%.
take this product, precision weighing, adding water to dissolve and quantitative dilution to make a solution containing about 2.5mg per lml, according to the law (General rule 0621), the specific rotation is 240 ° to 290 °.
take an appropriate amount of this product, add water to dissolve and make a solution containing 0.lg per lml, and determine it according to law (General 0631). The pH value should be 8.0~10.0.
take 5 parts of this product, each 0.6g, respectively, after adding water 5ml to dissolve, the solution should be clear and colorless; If it is turbid, compare with No. 1 turbidity standard solution (General rule 0902 first method), shall not be more concentrated; If the color is developed, it shall not be deeper in comparison with the yellow or yellow-green standard colorimetric solution No. 5 (general principles 0901 first method). When the solution is first dissolved, it can show a short pink color.
take an appropriate amount of this product, precision weighing, add mobile phase A to dissolve and quantitatively dilute before use. 0 mg of the solution was used as A test solution; 1ml was accurately weighed, placed in A 100ml measuring flask, diluted to the scale with mobile phase A, and shaken to obtain A control solution. Amoxicillin dimer (relative retention time is about 4.1) if there are impurity peaks in the chromatogram of the test solution. The peak area shall not be more than 3 times (3.0%) of the main peak area of the control solution; The peak area of other individual impurities shall not be more than 2 times (2.0%) of the main peak area of the control solution; the sum of each impurity peak area shall not be greater than 9 times (9.0%) of the main peak area of the control solution.
precision weigh 0.25g of this product, place it in the top empty bottle, add 5ml of water to dissolve, seal, and use it as a test solution. Precision weigh the appropriate amount of ethanol and methyl acetate, A solution containing about 0.3mg of ethanol and 0.2mg of methyl acetate per 1 ml was prepared by quantitative dilution with water, and 5ml was accurately weighed, placed in a headspace bottle, sealed, and used as a reference solution. Determined according to the residual solvent assay (General 0861 second method). Capillary column with 6% cyanopropylphenyl-94% dimethylpolysiloxane (or similar polar) as stationary liquid; Initial temperature is 33 ° C. For 6 minutes, the temperature was increased to 200°C at a rate of 30°C per minute for 6 minutes; The inlet temperature was 250°C. The detector temperature was 250°C; The equilibrium temperature of the headspace bottle was 80°C, the equilibration time was 30 minutes; The control solution was injected in Headspace, and the chromatogram was recorded. The resolution between peaks shall meet the requirements. The test solution and the reference solution were injected by Headspace, and the chromatograms were recorded. According to the external standard method to calculate the peak area, the residual amount of ethanol and methyl acetate should be in accordance with the provisions.
take this product, determination according to law (General Principles 0873), not over 1.0%.
take this product, according to the moisture determination method (General 0832 first method 1), the water content shall not exceed 3.0%.
take 5 parts of this product, each 2g, plus particle inspection water dissolution, inspection according to law (General 0904), should comply with the provisions. (For aseptic dispensing)
Take 3 parts of this product, and make a solution containing 50mg per 1 ml with water for particle inspection, and check it according to law (General rule 0903), no more than 6000 particles with lOum or more and no more than 600 particles with 25um and 25um in each lg sample. (For aseptic dispensing)
take this product, check according to law (General rule 1143), each 1 mg of amoxicillin (according to C16H19N3O5S) in the amount of endotoxin should be less than 0.15EU. (For injection)
take this product, dissolve and dilute with appropriate solvent, after membrane filtration treatment, inspection according to law (General rule 1101), should comply with the provisions. (For aseptic dispensing)
take the appropriate amount of this product, precision weighing, and mobile phase dissolution and quantitative dilution to make a solution containing about 0.5mg per lml, as a test solution, according to the method under amoxicillin, that's right.
B-lactam antibiotics, penicillins.
sealed and stored in a dry place.
This product is a sterile powder of amoxicillin sodium. Calculated as anhydrous, containing amoxicillin (according to C16H19N305S) shall not be less than 80.0%; Calculated as the average amount of juice, containing amoxicillin (according to C16H19N305S) shall be 90.0% ~ 110.0% of the label amount.
This product is white or off-white powder or crystal.
take this product, according to Amoxicillin Sodium under the identification test, showed the same results.
The contents under the item of loading amount difference were obtained by measuring according to the method under the item of Amoxicillin Sodium.
with Amoxicillin Sodium.
Based on C16H19N305S (l )0.5g (2) 1.0g(3)2.0g
light shielding, sealed storage.