(as' e tone).
Acetone contains NLT 99.0% of C3H6O, calculated on the anhydrous basis.
[CautionAcetone is very flammable. Do not use where it may be ignited. ]
• B. The retention time of the Sample corresponds to that of USP Acetone RS, as obtained in the Assay.
System suitability solution: Dilute 1.0 mL of USP Methyl Alcohol RS and 1.0 mL of USP Acetone RS with tetrahydrofuran to 50 mL.
Detector: Flame ionization
Column: 0.32-mm × 30-m fused-silica capillary; 1.8-µm of phase G43
Column: See Table 1.
Carrier gas: Helium
Flow rate: 35 cm/s (linear velocity)
Split ratio: 400:1
Injection volume: 1 µL
Sample: System suitability solution
[NoteThe relative retention times for methyl alcohol, acetone, and tetrahydrofuran are about 0.6, 1.0, and 1.9, respectively. ]
Resolution: NLT 15 between the methyl alcohol and acetone peaks
Calculate the percentage of acetone (C3H6O) in the portion of Acetone taken:
Result = (rU/rT) × 100
[NoteNo separate correction is applied for water content, because water does not respond to the flame-ionization detector. ]
Acceptance criteria: NLT 99.0% on the anhydrous basis
• Specific Gravity 841: NMT 0.789
• Nonvolatile Residue: Evaporate 50 mL in a tared porcelain dish on a steam bath, and dry at 105 for 1 h.
Acceptance criteria: The weight of the residue does not exceed 2 mg (0.004%).
Standard solution: Transfer 0.50 mL of water to a dry 100-mL volumetric flask, dilute with dehydrated isopropyl alcohol to volume, and mix.
Blank: Dehydrated isopropyl alcohol
Detector: Thermal conductivity
Column: 0.32-mm × 50-m capillary; 5.0-µm layer of support S2
Column: See Table 2.
Carrier gas: Helium
Flow rate: 11 mL/min
Split ratio: 4.5:1
Injection size: 1.0 µL
Samples: Acetone, Standard solution, and Blank
[NoteIdentify the peaks based on their relative retention times, which are 1.0 for water and about 1.9 for isopropyl alcohol. ]
Acceptance criteria: The area of the water peak for Acetone is NMT that from the Standard solution, corrected for the area of the water peak from the Blank (0.5%).
• Readily Oxidizable Substances
Analysis: Mix 20 mL with 0.10 mL of 0.10 N potassium permanganate in a glass-stoppered bottle.
Acceptance criteria: The permanganate color of the mixture does not completely disappear within 15 min.
• Packaging and Storage: Preserve in tight containers, remote from fire.
• USP Reference Standards 11
Auxiliary Information Please check for your question in the FAQs before contacting USP.
USP35NF30 Page 1682Pharmacopeial Forum: Volume No. 34(1) Page 120