Packaging and storage— Preserve in tight containers,and prevent exposure to excessive heat.

Specific gravity á841ñ: between 0.807and 0.809.

Distilling range,Method IIá721ñ— It distills within a range of 1.5,including 117.7.

Acidity— Titrate 74mL(60g)of it with 0.020Nalcoholic potassium hydroxide,using phenolphthalein TSas the indicator,until a pink color persists for not less than 15seconds:not more than 2.5mLis consumed.

Water,Method Iá921ñ: not more than 0.1%.

Limit of nonvolatile residue— Evaporate 100mLin a tared porcelain dish on a steam bath,and dry at 105for 30minutes:the weight of the residue does not exceed 4mg (0.004%).

Aldehydes— To 10mLof silver-ammonia-nitrate TSin a test tube add 10mLof Butyl Alcohol,and mix.Allow the mixture to stand in a dark place for 30minutes:no color is produced,although a slight precipitate may form at the interface of the two layers.

Butyl ether— Under typical conditions,the gas chromatograph (see Chromatography á621ñ)is equipped with a thermal conductivity detector,and contains a 6-mm ×2-m stainless steel column packed with 25%liquid phase G293,3¢-thiodipropionitrile on 30-to 40-mesh support S1C,maintained at a temperature of 85.Helium is used as the carrier gas at a flow rate of about 75mLper minute.Inject a suitable volume (about 10µL)of Butyl Alcohol,and measure the peak responses.Using these conditions,retention times are approximately 6.0minutes for butyl ether;12.0minutes for 2-butanol;17.0minutes for water;18.0minutes for isobutyl alcohol;and 25.0minutes for butyl alcohol:the response due to butyl ether is not more than 0.2%of the sum of all of the responses.

Expert Committee:(EMC)Excipients:Monograph Content

USP28–NF23Page 2967

Phone Number:1-301-816-8262