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Butylated Hydroxytoluene contains NLT 99.0% of C15H24O.
• A. Infrared Absorption 197K: On undried sample
• Residue on Ignition 281
Analysis: Transfer 50 g to a tared crucible, ignite until thoroughly charred, and cool. Moisten the ash with 1 mL of sulfuric acid, and complete the ignition by heating at 800 ± 25 for 15-min periods to constant weight.
Acceptance criteria: NMT 0.002%
• Heavy Metals, Method II 231: NMT 10 ppm
• Organic Impurities
Solution A: 50 mg/mL of potassium ferricyanide
Solution B: 105 mg/mL of ferric chloride
Sample solution: 20 mg/mL of Butylated Hydroxytoluene in methanol
Standard solution: 0.1 mg/mL of Butylated Hydroxytoluene from the Sample solution diluted with methanol
Absorbent: 0.25-mm layer of chromatographic silica gel mixture
Developing solvent system: Methylene chloride
Application volume: 10 µL
Spray reagent: Solution A, Solution B, and water (1:2:7), freshly prepared
Samples: Sample solution and Standard solution
Apply the Samples, and allow to dry. Place the plate in the chromatographic chamber, and develop until the solvent front has moved three-fourths of the length of the plate. Remove the plate, and allow the plate to dry. Spray the plate with Spray reagent.
Acceptance criteria: Any spot from the Sample solution, apart from the principal spot, is not more intense than the spot from the Standard solution (NMT 0.5%).
• Congealing Temperature 651: NLT 69.2, corresponding to NLT 99.0% of C15H24O
• Packaging and Storage: Preserve in well-closed containers.
• USP Reference Standards 11
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USP35NF30 Page 1718Pharmacopeial Forum: Volume No. 34(1) Page 130