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

Specific gravity 841: between 0.807 and 0.809.

Distilling range, Method II 721— It distills within a range of 1.5, including 117.7.

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

Water, Method I 921: not more than 0.1%.

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

Aldehydes— To 10 mL of silver-ammonia-nitrate TS in a test tube add 10 mL of Butyl Alcohol, and mix. Allow the mixture to stand in a dark place for 30 minutes: 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 621) is equipped with a thermal conductivity detector, and contains a 6-mm × 2-m stainless steel column packed with 25% liquid phase G29 3,3¢-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 75 mL per minute. Inject a suitable volume (about 10 µL) of Butyl Alcohol, and measure the peak responses. Using these conditions, retention times are approximately 6.0 minutes for butyl ether; 12.0 minutes for 2-butanol; 17.0 minutes for water; 18.0 minutes for isobutyl alcohol; and 25.0 minutes for butyl alcohol: the response due to butyl ether is not more than 0.2% of the sum of all of the responses.

Residual solvents 467: meets the requirements.

Expert Committee : (EM105) Excipient Monographs 1

USP29–NF24 Page 3285

Phone Number : 1-301-816-8262