White Wax
» White Wax is the product of bleaching and purifying Yellow Wax that is obtained from the honeycomb of the bee [Apis mellifera Linné (Fam. Apidae)] and that meets the requirements of the Saponification cloud test.
Packaging and storage—
Preserve in well-closed containers.
Saponification cloud test—
Place 3.00 g in a round-bottom, 100-mL boiling flask fitted with a ground-glass joint. Add 30 mL of a solution prepared by dissolving 40 g of potassium hydroxide in about 900 mL of aldehyde-free alcohol maintained at a temperature not exceeding 15
, and then when solution is complete, warming to room temperature and adding aldehyde-free alcohol to make 1000 mL. Reflux the mixture gently for 2 hours. At the end of this period, open the flask, insert a thermometer into the solution, and place the flask in a container of water at a temperature of 80. Rotate the flask in the bath while both the bath and the solution cool: the solution shows no cloudiness or globule formation before the temperature reaches 65.
, and then when solution is complete, warming to room temperature and adding aldehyde-free alcohol to make 1000 mL. Reflux the mixture gently for 2 hours. At the end of this period, open the flask, insert a thermometer into the solution, and place the flask in a container of water at a temperature of 80. Rotate the flask in the bath while both the bath and the solution cool: the solution shows no cloudiness or globule formation before the temperature reaches 65.
Fats or fatty acids, Japan wax, rosin, and soap—
Boil 1 g for 30 minutes with 35 mL of 3.5 N sodium hydroxide contained in a 100-mL beaker, maintaining the volume by the occasional addition of water, and allow the mixture to cool at room temperature for about 2 hours: the wax separates, leaving the liquid clear, turbid, or translucent, but not opaque. Filter the cool mixture, and acidify the clear filtrate with hydrochloric acid: the liquid remains clear or shows not more than a slight amount of turbidity or precipitate.
Acid value 
401
—
Warm about 3 g, accurately weighed, in a 200-mL flask with 25 mL of neutralized dehydrated alcohol until melted, shake the mixture, add 1 mL of phenolphthalein TS, and titrate the warm liquid with 0.5 N alcoholic potassium hydroxide VS to produce a permanent, faint pink color: the acid value so obtained is between 17 and 24.
401—
Warm about 3 g, accurately weighed, in a 200-mL flask with 25 mL of neutralized dehydrated alcohol until melted, shake the mixture, add 1 mL of phenolphthalein TS, and titrate the warm liquid with 0.5 N alcoholic potassium hydroxide VS to produce a permanent, faint pink color: the acid value so obtained is between 17 and 24.
Ester value 401—
To the solution resulting from the determination of Acid value add 25.0 mL of 0.5 N alcoholic potassium hydroxide VS and 50 mL of aldehyde-free alcohol, reflux the mixture for 4 hours, and titrate the excess alkali with 0.5 N hydrochloric acid VS. Perform a blank determination (see Residual Titrations under Titrimetry 541). The ester value so obtained is between 72 and 79.
401—
To the solution resulting from the determination of Acid value add 25.0 mL of 0.5 N alcoholic potassium hydroxide VS and 50 mL of aldehyde-free alcohol, reflux the mixture for 4 hours, and titrate the excess alkali with 0.5 N hydrochloric acid VS. Perform a blank determination (see Residual Titrations under Titrimetry 541). The ester value so obtained is between 72 and 79.
Auxiliary Information—
Please check for your question in the FAQs before contacting USP.
| Topic/Question | Contact | Expert Committee |
| Monograph | Hong Wang, Ph.D.
Scientist 1-301-816-8351 |
(EM205) Excipient Monographs 2 |
USP32–NF27 Page 1378