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USP Content of 4-Aminophenol in Acetaminophen by HPLC

Application ID : AN-1229/2

Analytes

  1. 4-Aminophenol, 2.Acetaminophen
Conditions

Column : Zodiac HST OG Column

Column Size : 250mm x 4.6mm,5µm

Mobile Phase :
Solution A : 10 mM phosphate buffer prepared : Add 0.60 g of mono basic potassium phosphate and 0.82g of anhydrous dibasic sodium phosphate to a 1L volumetric flask. Dissolve and dilute with water to to a pH of 7.0.
Solution B : Water
Solution C : Acetonitrile

Flow Rate : 1.0 mL/min

Buffer Details : 40 g/L of sodium citrate dihydrate and 1.5 g/L of anhydrous citric acid in water

Detector : 300 nm

Elution Mode : Gradient Program

Run Time : 10 min

Column Temperature : 30°C

Injection Volume : 10 µL

Description
4-Aminophenol (also known as p-aminophenol) is the primary degradation product and impurity (impurity K) in acetaminophen (paracetamol) containing drug products, formed via the hydrolysis of the active pharmaceutical ingredient.The method provides a clear seperation of chromatographic peak of 4-Amino phenol and Acetaminophen eluting at 3.578 and 4.586 minutes respectively.