Hydrocortisone EP Impurity N

Comparative study of two different chromatographic approaches for quantitation of hydrocortisone acetate and pramoxine hydrochloride in presence of their impurities
Fawzia Ibrahim a , Asmaa Kamal El-Deen a,b , Kuniyoshi Shimizu
Journal of Food and Drug Analysis Volume 26, Issue 3, July 2018, Pages 1160-1170
 
Novel stability indicating UHPLC method development and validation for simultaneous quantification of hydrocortisone acetate, pramoxine hydrochloride, potassium sorbate and sorbic acid in topical cream formulation
Lakshmi Narasimha RaoKatakamaThirupathiDongalabSanthosh KumarEttaboina
Talanta Open Volume 1, August 2020, 100004
 
Novel eco-friendly chromatographic determinations of hydrocortisone acetate, fusidic acid, their pharmacologically active impurities and pharmaceutical excipients: a comparative study
Maha M. Abdelrahman, Raghda Abdelmoneim Emam, Nouruddin W. Ali & Eglal A. Abdelaleem
Chemical Papers volume 74, pages2175–2187(2020)
 
An RP-HPLC Method for the Stability-Indicating Analysis of Impurities of Both Fusidic Acid and Betamethasone-17-Valerate in a Semi-Solid Pharmaceutical Dosage Form
Jonathan Byrne, Trinidad Velasco-Torrijos, Robert Reinhardt
Journal of Chromatographic Science, Volume 53, Issue 9, October 2015, Pages 1498–1503
 
Analytical method development and determination of hydrocortisone acetate and fusidic acid simultaneously in cream formulation, by reversed‐phase HPLC
Nawaz Rasool, Qudsia Kanwal, Muhammad Waseem
Biomedical Chromatography Volume35, Issue3 March 2021 e4997

Hydrocortisone EP Impurity N is chemically 11β,17,21-Trihydroxy-21-(11β,17,21-trihydroxy-3,20-dioxopregn-4-en-21-yl)pregn-4-ene-3,20-dione. It is also known as Hydrocortisone Symmetrical Dimer. Hydrocortisone EP Impurity N is supplied with detailed characterization data compliant with regulatory guideline. Hydrocortisone EP Impurity N can be used for the analytical method development, method validation (AMV), Quality Controlled (QC) application for Abbreviated New Drug Application (ANDA) or during commercial production of Hydrocortisone.

The product can be used as reference standards and further traceability against pharmacopeial standards (USP or EP) can be provided based on feasibility. SynZeal products are for analytical purpose only and not for human use.