Analysis of Inositol According to Japanese Pharmaceutical Excipients (KS-801)

According to Japanese Pharmaceutical Excipients 2018*, “Assay" for “Inositol" should be carried out with a column filled with strong acidic ion-exchange resin (Na-form). The SUGAR KS-801 confirmed the requirements were met.

System suitability requirementsElution order (Standard solution): inositol, the internal standard (1-propanol)
Resolution between inositol and the internal standard (Standard solution): ≥ 6
Relative standard deviation (RSD) of the peak area of the internal standard (Standard solution): ≤ 1.5% (repeated 6 times)

*The version at the time of the application acquisition.

Sample: 10 µL
(Standard solution) 4 mg/mL of Inositol and 12 mg/mL of 1-Propanol in H2O

  1. 1.Inositol
  2. 2.1-Propanol
Column
Shodex SUGAR KS-801 (8.0 mm I.D. x 300 mm)
Eluent
H2O
Flow rate
0.9 mL/min
Detector
RI
Column temp.
65 ℃

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