1. I.C.H. Topic Q3A (R2): Impurities in new Drug Substances. ICH Step 5. Note For Guidance on Impurities Testing: Impurities in New Drug Substances. CPMP/ICH/2737/99. European Medicines Agency, 2006.
2. HPLC separation of acetaminophen and its impurities using a mixed-mode reversed-phase/cation exchange stationary phase;Călinescu;J. Chromatogr. Sci.,2012
3. A validated, sensitive HPLC method for the determination of trace impurities in acetaminophen drug substance;Kamberi;J. Pharm. Biomed. Anal.,2004
4. Pharmaceutical impurities–a mini-review;Roy;AAPS Pharm. Sci.,2002
5. United States Pharmacopeia 42 Volume 1. Official Monographs: Acetaminophen. United States Pharmacopeial Convention, 12601, Twinbrook Parkway, Rockville, MD 20852. 2020; p:40–42.