Action and use
Non-selective phosphodiesterase inhibitor (xanthine); treatment of reversible airways obstruction.
DEFINITION
Etamiphylline Injection is a sterile solution of Etamiphylline Camsilate in Water for Injections.
The injection complies with the requirements stated under Parenteral Preparations and with the following requirements.
Content of etamiphylline camsilate, C13H21N5O2,C10H16O4S
95.0 to 105.0% of the stated amount.
IDENTIFICATION
Prepare a quantity of the residue as described in the Assay. The residue complies with the following tests.
A. The infrared absorption spectrum, Appendix II A, is concordant with the reference spectrum of etamiphylline (RSV 19).
B. Yields the reactions characteristic of xanthines, Appendix VI.
TESTS
Acidity
pH, 3.9 to 5.4, Appendix V L.
Related substances
Carry out the method for thin-layer chromatography, Appendix III A, using the following solutions.
(1) Dilute the injection with sufficient water to produce a solution containing 3.5% w/v of Etamiphylline Camsilate.
(2) Dilute 1 volume of solution (1) to 500 volumes with water.
CHROMATOGRAPHIC CONDITIONS
(a) Use as the coating silica gel HF254.
(b) Use the mobile phase as described below.
(c) Apply 10 μl of each solution.
(d) Develop the plate to 15 cm.
(e) After removal of the plate, allow it to dry in air and examine under ultraviolet light (254 nm).
MOBILE PHASE
1 volume of 13.5M ammonia, 20 volumes of ethanol (96%) and 80 volumes of chloroform.
LIMITS
Any secondary spot in the chromatogram obtained with solution (1) is not more intense than the spot in the chromatogram obtained with solution (2) (0.2%).
ASSAY
To a volume containing 0.7 g of Etamiphylline Camsilate add 15 mL of water, make alkaline with 5M ammonia and extract with three 25-mL quantities of chloroform, washing each extract with the same 5-mL quantity of water. Evaporate the combined extracts to dryness, dissolve the residue in 25 mL of water and titrate with 0.05M sulfuric acid VS using bromocresol green solution as indicator. Each mL of 0.05M sulfuric acid VS is equivalent to 51.16 mg of C13H21N5O2,C10H16O4S.
