Production of Ampicillin Trihydrate, Amoxicillin Trihydrate
Ampicillin Trihydrate and Amoxicillin Trihydrate are bulk APIs sales from China to all over the world.
Here is the RV and RSV for Ampicillin Trihydrate:
Part of the test method for Ampicillin Trihydrate
Ampicillin trihydrate contains not less than 96.0 per cent and not more than the equivalent of 100.5 per cent of (2S,5R,6R)-6-[[(2R)-2-amino-2-phenylacetyl]amino]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid, calculated with reference to the anhydrous substance.
Characters (Ampicillin Trihydrate)
A white, crystalline powder, slightly soluble in water, practically insoluble in alcohol, in ether and in fatty oils. It dissolves in dilute solutions of acids and of alkali hydroxides.
Identification (Ampicillin Trihydrate)
B, C, D.
A. Examine by infrared absorption spectrophotometry (2.2.24), comparing with the spectrum obtained with ampicillin trihydrate CRS.
B. Examine by thin-layer chromatography (2.2.27), using silanised silica gel H R as the coating substance.
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 ampicillin 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 of sodium hydrogen carbonate solution R.
Apply separately to the plate 1 ml of each solution. Develop over a path of 15 cm using a mixture of 10 volumes of acetone Rand 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.
D. It complies with the test for water (see Tests).