Analysis of Propylene Glycol Monocaprylate According to USP-NF Method (KF-801)

According to the United States Pharmacopeia and the National Formulary (USP 43-NF 38*), "ASSAY" for "Propylene Glycol Monocaprylate" should be carried out with a 7.0 mm (I.D.) x 60 cm (length) column filled with L21 packing material. Use of two GPC KF-801 columns, 8.0 mm (I.D.) x 30 cm (length) each, filled with L21 packing material in series with its flow rate adjusted in-relative to the column I.D. confirmed the requirement was met.

System suitability requirementRelative standard deviation (RSD) of monoester peak (Sample solution):≤ 2.0%

*The version at the time of the application acquisition.

Sample: 40 µL
(Sample solution) 40 mg/mL USP Propylene Glycol Monocaprylate Type I in eluent

  1. 1.Propylene glycol dicaprylate
  2. 2.Propylene glycol monocaprylate
chromatgram of polydextrose
Column
Shodex GPC KF-801 (8.0 mm I.D. x 300 mm) x 2
Eluent
THF
Flow rate
1.1 mL/min
Detector
RI
Column temp.
40 ℃

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