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        Ipecacuanha Syrup contains, in each 100 mL, not less than 0.12 g and not more than 0.15 g of the total alkaloids, calculated as emetine (C₂₉H₄₀N₂O₄) and cephaeline (C₂₈H₃₈N₂O₄).

        Ipecacuanha, in coarse powder a suitable quantity
        Glycerol   100 mL
        Simple Syrup, sufficient to produce 1000 mL
     Prepare the liquid extract using a mixture of 3 volumes of Ethanol and 1 volume of Purified Water to extract Ipecacuanha.  If necessary, evaporate the mixture under reduced pressure or add a suitable amount of Ethanol or Purified Water to obtain a solution containing, in each 100 mL, 1.7 to 2.1 g of the total alkaloids, emetine and cephaeline.  To 70 mL of this solution, add Glycerol 100 mL and Simple Syrup to make 1000 mL.

Description  Yellowish brown, viscous liquid; taste, sweet with a bitter after taste.  It has a sweet taste and a bitter aftertaste.  

Identification  Take 2 mL of the syrup into an evaporating dish, mix with 1 mL of hydrochloric acid, and add small pieces of chlorinated lime:  circumference of it turns orange.

Microbial limit  Complies with the requirements for Category 4A in the “Limit for Microbial Contamination” (Appendix 10.5).

Assay  Carry out the test as described in the “Liquid Chromatography” (Appendix 3.5).
     Standard preparation  Dissolve about 10 mg of Emetine Hydrochloride RS, previously dried over phosphorus pentoxide desiccant at 50° in vacuum for 5 hours and accurately weighed, in 0.01 M hydrochloric acid and dilute to 100.0 mL with the same solvent.
     Assay preparation  Dilute 5.0 mL of Ipecac Syrup to 50.0 mL with 0.01 M hydrochloric acid.
     Resolution solution  Dissolve 1 mg each of Emetine Hydrochloride RS and cephaeline hydrobromide in 10 mL of 0.01 M hydrochloric acid. 
     Mobile phase  A 0.4 per cent w/v solution of sodium 1-heptane sulfonate and methanol (1:1), prepared by dissolving 2.0 g of sodium 1-heptane sulfonate in 500 mL of water, adjusting the pH to 4.0 with glacial acetic acid, and adding 500 mL of methanol.
     Chromatographic System
          DETECTOR Ultraviolet light (283 nm).
          COLUMN  A stainless steel column (15 cm × 4.6 mm), packed with octadecylsilyl bonded to porous silica or ceramic microparticles (5 µm).
          COLUMN TEMPERATURE  50°
          FLOW RATE  Adjust so that the retention time of emetine is about 14 minutes.
     System Suitability
          Sample  Resolution solution
     Suitability requirements
          RESOLUTION  Not less than 5.0 between cephaeline and emetine peaks.
          RELATIVE STANDARD DEVIATION  Not more than 1.5 per cent for emetine.
     Procedure  Separately inject equal volumes (about 10 mL) of Standard preparation and Assay preparation into the chromatograph, record the chromatograms, and measure the responses for the major peaks.  Identify the peaks due to cephaeline and emetine in the assay preparation using the retention times of emetine and cephaeline in the standard preparation and the resolution solution.
     Calculation  Calculate the content of total alkaloids, calculated as cephaeline and emetine, in the portion of the Ipecacuanha Syrup taken by the expression,

W [A_U1 + (A_U2 ´ 0.971)]/A_S ´ 1/2 ´ 0.868

in which A_U1 and A_U2 are the areas of the peaks due to emetine and cephaeline, respectively, obtained from Assay preparation; A_S is the area of the peak due to emetine obtained from Standard preparation; W is the weight, in mg, of Emetine Hydrochloride RS in Standard preparation.  (Note  1 mg of emetine hydrochloride contains 0.868 mg of emetine and correction factor for cephaeline is 0.971.)

Other requirements  Complies with the requirements described under “Oral Liquids” (Appendix 1.16).