Analysis of Mannitol Compounded Injection According to USP-NF Method (SP0810)

The monograph below became official on December 1, 2024.

According to the United States Pharmacopeia and the National Formulary Pharmacopeial Forum (PF 48(4)*), mannitol assay of "Mannitol Compounded Injection" should be carried out with an HPLC and a column filled with L22 packing material, and meets following requirements. The use of SUGAR SP0810, a sugar analysis column, confirmed the requirements were met.

 

System suitability requirements Tailing factor of mannitol: ≤ 2.0
Relative standard deviation (RSD): ≤ 2.0%


*The version at the time of the application acquisition.

Sample: 80 μL

  1. 1.USP Mannitol RS 2.5 mg/mL
Column
Shodex SUGAR SP0810 (8.0 mm I.D. x 300 mm)
Eluent
H2O
Flow rate
1.0 mL/min
Detector
RI
Column temp.
80 ℃

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