Amoxicilline Trihydrate information
For more detailed Amoxicillin Trihydrate information, please turn to our product Page:
Amoxicilline Trihydrate is the raw material of Amoxicilline. It is anti-biotic.
Usually, granular form is used to produce capsules.
While the powder form Amoxicilline Trihydrate is used to produce oral solutions, tablets, or pills.
The difference with the granular and powder form is just the particle size and the final usage.
They are the same substance, with exact chemical properties.
Here is part of the test method for Amoxicilline Trihydrate according to EP specifications:
A. Examine by infrared absorption spectrophotometry (2.2.24), comparing with the spectrum obtained with amoxicillin trihydrate CRS.
B. Examine by thin-layer chromatography (2.2.27), using silanised silica gel H R as the coating substance.
Test solution. Dissolve 25 mg of the substance to be examined in 10 ml of sodium hydrogen carbonate solution R.
Reference solution (a). Dissolve 25 mg of amoxicillin trihydrate CRS in 10 ml of sodium hydrogen carbonate solution R.
Reference solution (b). Dissolve 25 mg of amoxicillin trihydrate CRS and 25 mg of ampicillin trihydrate CRS in 10 ml ofsodium hydrogen carbonate solution R.
Apply to the plate 1 ml of each solution. Develop over a path of 15 cm using a mixture of 10 volumes of acetone R and 90 volumes of a 154 g/l solution of ammonium acetate R, the pH of which has been adjusted to 5.0 with glacial acetic acid R. Allow the plate to dry in air and expose it to iodine vapour until the spots appear. Examine in daylight. The principal spot in the chromatogram obtained with the test solution is similar in position, colour and size to the principal spot in the chromatogram obtained with reference solution (a). The test is not valid unless the chromatogram obtained with reference solution (b) shows 2 clearly separated spots.
C. Place about 2 mg in a test-tube about 150 mm long and 15 mm in diameter. Moisten with 0.05 ml of water R and add 2 ml of sulphuric acid-formaldehyde reagent R. Mix the contents of the tube by swirling; the solution is practically colourless. Place the test-tube in a water-bath for 1 min; a dark yellow colour develops.
Solution S: With the aid of ultrasound or gentle heating, dissolve 0.100 g in carbon dioxide-free water R and dilute to 50.0 ml with the same solvent.
Appearance of solution:
Dissolve 1.0 g in 10 ml of 0.5 M hydrochloric acid. Dissolve separately 1.0 g in 10 ml of dilute ammonia R2. Immediately after dissolution, the solutions are not more opalescent than reference suspension II (2.2.1).
pH (2.2.3) -- Amoxicilline Trihydrate
The pH of solution S is 3.5 to 5.5.
Specific optical rotation (2.2.7)
+ 290 to + 315, determined on solution S and calculated with reference to the anhydrous substance.
Related substances (Amoxicilline Trihydrate according to EP Standard)
Examine by liquid chromatography (2.2.29) adjusting the ratio A:B of the mobile phase and the attenuation as described under Assay. Inject reference solution (d). Inject a freshly prepared test solution (b) and start the elution isocratically with the chosen mobile phase. Immediately after elution of the amoxicillin peak start a linear gradient elution to reach a mobile phase A:B of 0:100 over a period of 25 min. Continue the chromatography with mobile phase B for 15 min, then equilibrate the column for 15 min with the mobile phase chosen originally. Inject mobile phase A and use the same elution gradient to obtain a blank. In the chromatogram obtained with test solution (b), the area of any peak, apart from the principal peak and any peak observed in the blank chromatogram, is not greater than the area of the principal peak in the chromatogram obtained with reference solution (d) (1 per cent).
N,N-Dimethylaniline (2.4.26, Method B)
Not more than 20 ppm.
If you want to buy Amoxicilline Trihydrate raw material, we will be your perfect choice.