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Analysis of Epinephrine According to USP-NF (In-Process Revision) (CDBS-453)

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In-Process Revision of Pharmacopeia Forum 44 (6) of the United States Pharmacopeia and the National Formulary (USP-NF), to determine the optical purity of epinephrine injection, analytical methods using L45 packing material have been published. The ORpak CDBS-453, a column for chiral separation, confirmed the following requirements were met.
System suitability requirements:
 Resolution of (R) -epinephrine and (S) -epinephrine :Rs ≧ 1.5
 Relative standard deviation of the peak area (RSD): ≦ 2.0 %
 The signal / noise ratio in the sensitivity solution:≧ 10


Sample : 10 μL
System suitability solution (Epinephrine hydrochloride 20 μg/mL (in *Solution A))
1. (R)-Epinephrine
2. (S)-Epinephrine

Column       : Shodex ORpak CDBS-453 (4.6 mm I.D. x 150 mm)
Eluent       : *Solution A/CH3CN=99/1
Flow rate    : 0.3 mL/min
Detector     : UV (280 nm)
Column temp. : 25 °C
*: 0.75 g/L Ammonium acetate aqueous solution adjusted to pH 4.0 
     with Glacial acetic acid