(bue' ti lay'' ted hye drox'' ee an' i sole).
Butylated Hydroxyanisole contains NLT 98.5% of C11H16O2.
• A. Procedure
Analysis: To 5 mL of 0.1 mg/mL solution in 72% alcohol add 2 mL of 20 mg/mL sodium borate solution and 1 mL of 0.1 mg/mL solution of 2,6-dichloroquinone-chlorimide in dehydrated alcohol, and mix.
Acceptance criteria: A blue color is produced.
B. The retention times of 3-tert-butyl-4-hydroxyanisole and 2-tert-butyl-4-hydroxyanisole from the Sample solution correspond to those from the Standard solution, as obtained in the Assay.
Solution A: 5% acetic acid
Mobile phase: Acetonitrile and Solution A (45:55)
Standard solution: 90 µg/mL of USP 3-tert-Butyl-4-hydroxyanisole RS and 10 µg/mL of USP 2-tert-Butyl-4-hydroxyanisole RS in Mobile phase
Sample solution: 100 µg/mL of Butylated Hydroxyanisole in Mobile phase
Detector: UV 290 nm
Column: 4.6-mm × 75-mm; 3.5-µm packing L1
Column temperature: 30
Flow rate: 1.2 mL/min
Injection size: 20 µL
Sample: Standard solution
[NoteThe retention times of 2-tert-butyl-4-hydroxyanisole and 3-tert-butyl-4-hydroxyanisole are about 4.2 and 4.6 min, respectively. ]
Resolution: NLT 1.5 between the 3-tert-butyl-4-hydroxyanisole isomer and 2-tert-butyl-4-hydroxyanisole isomer peaks
Tailing factor: NMT 1.5
Relative standard deviation: NMT 2.0% for the 3-tert-butyl-4-hydroxyanisole isomer and 2-tert-butyl-4-hydroxyanisole isomer peaks
Samples: Standard solution and Sample solution
Measure the peak areas for each isomer. Calculate the percentage of each isomer in the portion of Butylated Hydroxyanisole taken:
Result = (rU/rS) × (CS/CU) × 100
[NoteCalculate the percentage of C11H16O2 in the portion of Butylated Hydroxyanisole taken by adding the quantities of the two isomers. ]
Acceptance criteria: NLT 98.5%
• Residue on Ignition 281: NMT 0.01%, determined on a 10-g specimen
• Heavy Metals, Method II 231: NMT 10 ppm
• Packaging and Storage: Preserve in well-closed containers.
• USP Reference Standards 11
USP 2-tert-Butyl-4-hydroxyanisole RS
USP 3-tert-Butyl-4-hydroxyanisole RS
Auxiliary Information Please check for your question in the FAQs before contacting USP.
USP35NF30 Page 1717Pharmacopeial Forum: Volume No. 35(6) Page 1503