Betamethasone Dipropionate EP Impurity H

Application of LC–MSn in conjunction with mechanism-based stress studies in the elucidation of drug impurity structure: Rapid identification of a process impurity in betamethasone 17-valerate drug substance
Min Li, Mingxiang Lin, Abu Rustum
Journal of Pharmaceutical and Biomedical Analysis 48 (2008) 1451–1456
 
Development and Validation of Stability-indicating HPLC Method for Betamethoasone Dipropionate and Related Substances in Topical Formulation
A. s. vairale*, p. sivaswaroop1 and s. bandana
Indian Journal of Pharmaceutical Sciences 74(2):107-15

Betamethasone Dipropionate EP Impurity H is chemically 6α-Bromo-9-fluoro-11β-hydroxy-16β-methyl-3,20-dioxopregna-1,4-diene-17,21-diyl dipropanoate (as per EP). It is also known as 6α-Bromo-Betamethasone Dipropionate (EP) ; Betamethasone Dipropionate USP Related Compound H. Betamethasone Dipropionate EP Impurity H is supplied with detailed characterization data compliant with regulatory guideline. Betamethasone Dipropionate EP Impurity H 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 Betamethasone.

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.