Lanolin Alcohols
»Lanolin Alcohols is a mixture of aliphatic alcohols,triterpenoid alcohols,and sterols,obtained by the hydrolysis of Lanolin.It may contain not more than 0.1percent of a suitable antioxidant.
Packaging and storage—
Preserve in well-closed,light-resistant containers,preferably at controlled room temperature.
Identification—
Dissolve 0.5g in 5mLof chloroform,and add 1mLof acetic anhydride and 2drops of sulfuric acid:a green color is produced.
Melting range,Class IIá741ñ:
not below 56
.
.
Acidity and alkalinity—
Boil 10g with 100mLof water for 5minutes,with frequent stirring.Remove the source of heat,add 0.5mLof phenolphthalein TS,and stir:no pink color is produced.Add 0.5mLof methyl orange TS,and stir:no red color is produced.
Loss on drying á731ñ—
Dry it at 105for 1hour:it loses not more than 0.5%of its weight.
for 1hour:it loses not more than 0.5%of its weight.
Residue on ignition á281ñ:
not more than 0.15%.
Copper—
Heat 5.0g over a small flame until charred,ignite the residue at about 550,and dissolve the ash in 5mLof hydrochloric acid,with the aid of heat.Cool,dilute with water,render alkaline with ammonium hydroxide,boil to remove the excess of ammonia,add a few drops of bromine TS,boil again,and filter.To the filtrate add 1mLof sodium diethyldithiocarbamate solution (1in 1000),a few drops of 6Nammonium hydroxide,and sufficient water to bring the volume to 50mL.The resulting color is not darker than that produced by adding 1mLof the sodium diethyldithiocarbamate solution and a few drops of 6Nammonium hydroxide to 2.5mLof a 0.00393%solution of cupric sulfate,and diluting with water to 50mL(5ppm).
,and dissolve the ash in 5mLof hydrochloric acid,with the aid of heat.Cool,dilute with water,render alkaline with ammonium hydroxide,boil to remove the excess of ammonia,add a few drops of bromine TS,boil again,and filter.To the filtrate add 1mLof sodium diethyldithiocarbamate solution (1in 1000),a few drops of 6Nammonium hydroxide,and sufficient water to bring the volume to 50mL.The resulting color is not darker than that produced by adding 1mLof the sodium diethyldithiocarbamate solution and a few drops of 6Nammonium hydroxide to 2.5mLof a 0.00393%solution of cupric sulfate,and diluting with water to 50mL(5ppm).
Acid value á401ñ:
not more than 2.
Saponification value á401ñ:
not more than 12,a 5-g specimen of molten Lanolin Alcohols being refluxed with the alcoholic potassium hydroxide for 4hours.
Content of sterols (as cholesterol)—
Melt 20g of Lanolin Alcohols on a water bath,mix,and allow to cool.Dissolve about 100mg,accurately weighed,in 12mLof warm (about 60)90percent alcohol.Allow to stand for 18hours,pass through a medium-porosity,sintered-glass filter,and wash the residue with two 15-mLportions of 90percent alcohol.Combine the filtrate and washings,add 20mLof a freshly prepared 1in 100solution of digitonin in 90percent alcohol,and warm to 60.Allow to cool,pass through a medium-porosity,sintered-glass filter with the aid of gentle vacuum,wash the residue with 10mLof 90percent alcohol,and dry at 105to constant weight.Each g of residue is equivalent to 0.239g of cholesterol:not less than 30.0%of sterols,calculated as cholesterol,is found.
)90percent alcohol.Allow to stand for 18hours,pass through a medium-porosity,sintered-glass filter,and wash the residue with two 15-mLportions of 90percent alcohol.Combine the filtrate and washings,add 20mLof a freshly prepared 1in 100solution of digitonin in 90percent alcohol,and warm to 60.Allow to cool,pass through a medium-porosity,sintered-glass filter with the aid of gentle vacuum,wash the residue with 10mLof 90percent alcohol,and dry at 105to constant weight.Each g of residue is equivalent to 0.239g of cholesterol:not less than 30.0%of sterols,calculated as cholesterol,is found.
Auxiliary Information—
Staff Liaison:Catherine Sheehan,B.Sc.,Scientist
Expert Committee:(EMC)Excipients:Monograph Content
USP28–NF23Page 3025
Phone Number:1-301-816-8262