- British Pharmacopoeia Volume III
- Formulated Preparations: Specific Monographs
Adrenaline Injection / Epinephrine Injection |
Adrenaline Tartrate Injection
Epinephrine Tartrate Injection
Adrenoceptor agonist.
Adrenaline Injection is a sterile, isotonic solution containing 0.18% w/v of Adrenaline Acid Tartrate in Water for Injections.
The injection complies with the requirements stated under Parenteral Preparations and with the following requirements.
0.09 to 0.11% w/v.
A colourless solution.
A. In the Assay, the principal peak in the chromatogram obtained with solution (1) has the same retention time as that in the chromatogram obtained with solution (2).
B. To 1 mL add a 0.25% w/v solution of iron(iii) chloride hexahydrate drop wise until a green colour is produced. On the gradual addition of sodium hydrogen carbonate solution, the solution changes first to blue and then to red.
C. To 10 mL add 2 mL of a 10% w/v solution of disodium hydrogen orthophosphate and sufficient iodinated potassium iodide solution to produce a brown colour and remove excess iodine by adding 0.1m sodium thiosulfate drop wise. A red colour is produced.
pH, 2.8 to 3.6, Appendix V L.
Carry out the method for liquid chromatography, Appendix III D, using the following solutions.
(1) Use the injection.
(2) 0.0018% w/v of noradrenaline acid tartrate in the mobile phase.
(3) 0.0018% w/v of adrenaline acid tartrate BPCRS and 0.0018% w/v of noradrenaline acid tartrate in the mobile phase.
(a) Use a stainless steel column (10 cm × 4.6 mm) packed with end-capped octadecylsilyl silica gel for chromatography (5 µm) (Nucleosil C18 is suitable).
(b) Use isocratic elution and the mobile phase described below.
(c) Use a flow rate of 2 mL per minute.
(d) Use an ambient column temperature.
(e) Use a detection wavelength of 205 nm.
(f) Inject 20 µL of each solution.
4.0 g of tetramethylammonium hydrogen sulfate, 1.1 g of sodium heptanesulfonate and 2 mL of 0.1m disodium edetate in a mixture of 50 mL of methanol and 950 mL of water adjusted to pH to 3.5 with 1m sodium hydroxide.
The test is not valid unless, in the chromatogram obtained with solution (3), the resolution factor between the two principal peaks is at least 2.0.
In the chromatogram obtained with solution (1):
the area of any peak corresponding to noradrenaline is not greater than the area of the principal peak in the chromatogram obtained with solution (2)(1%).
Carry out the method for liquid chromatography, Appendix III D, using the following solutions in the mobile phase.
(1) Dilute 1 volume of the injection to 10 volumes.
(2) 0.02% w/v of adrenaline acid tartrate BPCRS.
(3) 0.02% w/v of adrenaline acid tartrate BPCRS and 0.02% w/v of noradrenaline acid tartrate.
The chromatographic conditions described under Noradrenaline may be used.
4.0 g of tetramethylammonium hydrogen sulfate, 1.1 g of sodium heptanesulfonate and 2 mL of 0.1m disodium edetate to a mixture of 50 mL of methanol and 950 mL of water adjusted to pH 3.5 with 1m sodium hydroxide.
The test is not valid unless, in the chromatogram obtained with solution (3), the resolution factor between the two principal peaks is at least 2.0.
Calculate the content of C9H13NO3 in the injection using the declared content of C9H13NO3 in adrenaline acid tartrate BPCRS.
Adrenaline Injection should be protected from light.
The quantity of active ingredient is stated in terms of the equivalent amount of adrenaline (epinephrine).
Adrenaline Injection contains the equivalent of adrenaline (epinephrine), 1 in 1000 (1 mg in 1 mL).