Analysis of Ascorbic Acid Injection According to USP-NF Method (DM-614)

According to the United States Pharmacopeia and the National Formulary (USP 40-NF 35*), "ASSAY" for "Ascorbic Acid Injection" should be carried out with a column filled with L39 packing material. The RSpak DM-614, a column filled with L39 packing material, confirmed the requirements were met.

System suitability requirementsTheoretical plate number (Standard solution): ≥ 3,500
Tailing factor (Standard solution): ≤ 1.6
Relative standard deviation (RSD) (Standard solution): ≤ 1.5 %

*The version at the time of the application acquisition.

Sample: 4 µL
(Standard solution) 0.5 mg/mL of Ascorbic Acid in eluent

  1. 1.Ascorbic acid
Column
：Shodex RSpak DM-614 (6.0 mm I.D. x 150 mm)
Eluent
：0.055 M Na2HPO4 + 0.045 M KH2PO4 aq. (adjusted pH2.5 with H3PO4 aq.)
Flow rate
：0.6 mL/min
Detector
：UV (245 nm)
Column temp.
：30 ℃

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