White Wax
DEFINITION
White Wax is the product of bleaching and purifying Yellow Wax that is obtained from the honeycomb of the bee [Apis mellifera L. (Fam. Apidae)] and that meets the requirements of the Saponification Cloud Test.
SPECIFIC TESTS
• Saponification Cloud Test
Sample:
3.00 g
Alcoholic potassium hydroxide:
Dissolve 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, warm to room temperature, and add aldehyde-free alcohol to make 1000 mL.
, and then when solution is complete, warm to room temperature, and add aldehyde-free alcohol to make 1000 mL.
Analysis:
Place the Sample in a 100-mL round-bottom boiling flask fitted with a ground-glass joint. Add 30 mL of Alcoholic potassium hydroxide. Reflux the mixture gently for 2 h. 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.
. Rotate the flask in the bath while both the bath and the solution cool.
Acceptance criteria:
The solution shows no cloudiness or globule formation before the temperature reaches 65.
.
• Fats or Fatty Acids, Japan Wax, Rosin, and Soap
Sample:
1 g
Analysis 1:
Boil the Sample for 30 min with 35 mL of 3.5 N sodium hydroxide contained in a 100-mL beaker, maintaining the volume of solution by the occasional addition of water, and allow the mixture to cool at room temperature for about 2 h.
Acceptance criteria 1:
The wax separates, leaving the liquid clear, turbid, or translucent, but not opaque.
Analysis 2:
Filter the cool mixture obtained in Analysis 1, and acidify the clear filtrate with hydrochloric acid.
Acceptance criteria 2:
The liquid remains clear or shows NMT a slight amount of turbidity or precipitate.
• Fats and Fixed Oils, Acid Value 
401
401
Sample:
3 g
Analysis:
Warm the Sample in a 200-mL flask with 25 mL of neutralized dehydrated alcohol until melted, then 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. Calculate the acid value as directed in the chapter.
Acceptance criteria:
17–24
• Fats and Fixed Oils, Ester Value 401
401
Sample solution:
The solution resulting from the determination of Acid Value
Analysis:
To the Sample solution add 25.0 mL of 0.5 N alcoholic potassium hydroxide VS and 50 mL of aldehyde-free alcohol, and reflux the mixture for 4 h. Titrate the excess alkali with 0.5 N hydrochloric acid VS. Perform a blank determination (see Titrimetry 541, Residual Titrations). Calculate the ester value as directed in the chapter.
541, Residual Titrations). Calculate the ester value as directed in the chapter.
Acceptance criteria:
72–79
ADDITIONAL REQUIREMENTS
• Packaging and Storage:
Preserve in well-closed containers.
Auxiliary Information—
Please check for your question in the FAQs before contacting USP.
| Topic/Question | Contact | Expert Committee |
|---|---|---|
| Monograph | Robert H. Lafaver, M.S.
Scientific Liaison 1-301-816-8335 |
(EXC2010) Monographs - Excipients |
USP35–NF30 Page 2016