Opium Tincture
»Opium Tincture contains,in each 100mL,not less than 0.90g and not more than 1.10g of anhydrous morphine.
Opium Tincture may be prepared as follows.
Place 100g of granulated or sliced Opium in a suitable vessel.[NOTE—Do not use Powdered Opium.]Add 500mLof boiling water,and allow to stand,with frequent stirring,for 24hours.Transfer the mixture to a percolator,allow it to drain,percolate with water as the menstruum to complete extraction,and evaporate the percolate to a volume of 400mL.Boil actively for not less than 15minutes,and allow to stand overnight.Heat the mixture to 80,add 50g of paraffin,and heat until the paraffin is melted.Beat the mixture thoroughly,and cool.
Remove the paraffin,and filter the concentrate,washing the paraffin and the filter with sufficient water to make the filtrate measure 750mL.Add 188mLof alcohol to the filtrate,mix,and assay a 10-mLportion of the resulting solution as directed in the Assay.Dilute the remaining solution with a mixture of 1volume of alcohol and 4volumes of water to obtain a Tincture containing 1g of anhydrous morphine in each 100mL.Mix.
Packaging and storage— Preserve in tight,light-resistant containers,and avoid exposure to direct sunlight and to excessive heat.
Alcohol content á611ñ: between 17.0%and 21.0%of C2H5OH,determined by the gas-liquid procedure,acetone being used as the internal standard.
Assay—
Chromatographic tubes ,Citrate buffer,Standard preparation,and Chromatographic columns—Prepare as directed in the Assayunder Paregoric.
Assay preparation— Transfer 10.0mLof Tincture to a 50-mLvolumetric flask containing 10.0mLof alcohol,add purified water to volume,and mix.Transfer a 2.0-mLaliquot of the solution,equivalent to about 4mg of Morphine,to a 50-mLbeaker,and add 0.5mLof Citrate buffer.
Procedure— Proceed as directed for Procedurein the Assayunder Paregoric.Calculate the weight of anhydrous morphine,in g per 100mLof the Tincture taken by the formula:
0.250W(AU/AS),
in which Wis the weight,in mg,of anhydrous morphine in the 50mLof Standard preparation,and AUand ASare the corrected absorbances of the solution from the Assay preparationand the Standard preparation,respectively.
Auxiliary Information— Staff Liaison:Gabriel I.Giancaspro,Ph.D.,Senior Scientist and Latin American Specialist
Expert Committee:(DSB)Dietary Supplements:Botanicals
USP28–NF23Page 1422
Phone Number:1-301-816-8343