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Acetyltributyl Citrate contains NLT 99.0% of C20H34O8, calculated on the anhydrous basis.
• B. The retention time of the Sample solution corresponds to that of a similar preparation of USP Acetyltriethyl Citrate RS, as obtained in the Assay.
System suitability solution: 30 mg/mL each of USP Acetyltributyl Citrate RS and USP Tributyl Citrate RS in toluene
Sample solution: 30 mg/mL of Acetyltributyl Citrate in toluene
Detector: Flame ionization
Column: 0.32-mm × 30-m, bonded with a 0.5-µm layer of phase G42
Column: See the temperature program table below.
Flow rate: 1.9 mL/min
Carrier gas: Helium
Injection type: Split, 30:1
Injection size: 1 µL
Sample: System suitability solution
[NoteThe relative retention times for tributyl citrate and acetyl tributyl citrate are 0.9 and 1.0, respectively. ]
Resolution: NLT 1.5 between tributyl citrate and acetyl tributyl citrate
Relative standard deviation: NMT 2.0% determined from both the tributyl citrate and acetyl tributyl citrate peaks, based on area percent calculation
Sample: Sample solution
[NoteMeasure all of the peak areas, excluding the solvent peak. ]
Calculate the percentage of C20H34O8 in the portion of Acetyltributyl Citrate taken:
Result = (rU/rT) ×100
Acceptance criteria: NLT 99.0% on the anhydrous basis
• Heavy Metals, Method II 231: NMT 10 ppm
• Specific Gravity 841: 1.0451.055
• Refractive Index 831: 1.44101.4425
Neutralized isopropyl alcohol: To a suitable quantity of isopropyl alcohol add 23 drops of bromothymol blue TS and just sufficient 0.10 N sodium hydroxide dropwise to produce a faint blue color. [NotePrepare Neutralized isopropyl alcohol just before use. ]
Sample solution: 32.0 g of Acetyltributyl Citrate in 30 mL of Neutralized isopropyl alcohol
Analysis: Add bromothymol blue TS. Titrate with 0.10 N sodium hydroxide to a faint blue endpoint.
Acceptance criteria: NMT 1.0 mL of 0.10 N sodium hydroxide is required.
• Water Determination, Method I 921: NMT 0.25%
• Packaging and Storage: Preserve in tight containers.
• USP Reference Standards 11
Auxiliary Information Please check for your question in the FAQs before contacting USP.
USP35NF30 Page 1683Pharmacopeial Forum: Volume No. 35(6) Page 1495