Acetone
(as' e tone).
Click to View Image

C3H6O 58.08
2-Propanone;    
Acetone     [67-64-1].
DEFINITION
Acetone contains NLT 99.0% of C3H6O, calculated on the anhydrous basis.
[Caution—Acetone is very flammable. Do not use where it may be ignited. ]
IDENTIFICATION
•  B. The retention time of the Sample corresponds to that of USP Acetone RS, as obtained in the Assay.
ASSAY
•  Procedure
Sample:  Acetone
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.
Chromatographic system 
Mode:  GC
Detector:  Flame ionization
Column:  0.32-mm × 30-m fused-silica capillary; 1.8-µm of phase G43
Temperature 
Column:  See Table 1.
Table 1
Initial
Temperature
()
Temperature
Ramp
(/min)
Final
Temperature
()
Hold Time at Final
Temperature
(min)
40 0 40 5
40 20 240
Injector:  200
Detector:  280
Carrier gas:  Helium
Flow rate:  35 cm/s (linear velocity)
Split ratio:  400:1
Injection volume:  1 µL
System suitability 
Sample:  System suitability solution
[Note—The relative retention times for methyl alcohol, acetone, and tetrahydrofuran are about 0.6, 1.0, and 1.9, respectively. ]
Suitability requirements 
Resolution:  NLT 15 between the methyl alcohol and acetone peaks
Analysis 
Sample:  Sample
Calculate the percentage of acetone (C3H6O) in the portion of Acetone taken:
Result = (rU/rT) × 100
rU== peak area due to the acetone peak in the Sample
rT== sum of the areas of all the peaks in the Sample
[Note—No 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 TESTS
•  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%).
•  Water
Sample:  Acetone
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
Chromatographic system 
Mode:  GC
Detector:  Thermal conductivity
Column:  0.32-mm × 50-m capillary; 5.0-µm layer of support S2
Temperature 
Column:  See Table 2.
Table 2
Initial
Temperature
()
Temperature
Ramp
(/min)
Final
Temperature
()
Hold Time at Final
Temperature
(min)
100 25 190
Injector:  250
Detector:  250
Carrier gas:  Helium
Flow rate:  11 mL/min
Split ratio:  4.5:1
Injection size:  1.0 µL
Analysis 
Samples:  Acetone, Standard solution, and Blank
[Note—Identify 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.
ADDITIONAL REQUIREMENTS
•  Packaging and Storage: Preserve in tight containers, remote from fire.
•  USP Reference Standards 11
USP Acetone RS Click to View Structure
USP Methyl Alcohol RS Click to View Structure
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
Reference Standards RS Technical Services
1-301-816-8129
rstech@usp.org
USP35–NF30 Page 1682
Pharmacopeial Forum: Volume No. 34(1) Page 120