Packaging and storage— Preserve in tight containers,protected from light,and store in a cold place.

Alcohol content,Method Iá611ñ: between 65.0%and 70.0%of C2H5OH.

Assay— Transfer 2.0mLof Compound Orange Spirit and 1.0mLof kerosene to a Babcock bottle,graduated to 8%,and mix.Add sufficient saturated calcium chloride solution,acidified with hydrochloric aid,to almost fill the bulb of the bottle.Rotate the bottle vigorously to ensure mixing,then add a sufficient quantity of the calcium chloride solution to bring the separated oil into the neck of the bottle.Centrifuge for 5minutes at about 1500rpm,and read the volume of oil in the stem.Subtract five divisions on the volumetric flask for the kerosene added,and multiply the remaining number of divisions by 10.5to obtain the volume,in mL,of mixed oils in 100mLof the Compound Orange Spirit.

Expert Committee:(CRX)Compounding Pharmacy

USP28–NF23Page 3044

Phone Number:1-301-816-8243