Metolazone EP Impurity B

Determination of a Metolazone metabolite in human urine by high‐performance liquid chromatography/diode‐array detection, high‐performance liquid chromatography/electrospray ionization mass spectrometry and gas chromatography/mass spectrometry
Yunje Kim  Sungil Kim  Myungsoo Kim  Won Lee
Rapid Commun. Mass Spectrom. 2004; 18: 917–922
 
Analytical method development and validation of simultaneous estimation of Metolazone and Spironolactone in bulk and pharmaceutical dosage form by RP-HPLC
G.Pallavi , A.Ravi Kumar
Indian Journal of Research in Pharmacy and Biotechnology 2(6) ; 2320 – 3471

Metolazone EP Impurity B is chemically (2RS)-7-chloro-2-methyl-3-(4-methylphenyl)-4-oxo-1,2,3,4-tetrahydroquinazoline-6-sulfonamide (as per EP). It is also known as Metolazone USP Related Compound D. Metolazone EP Impurity B is supplied with detailed characterization data compliant with regulatory guideline. Metolazone EP Impurity B 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 Metolazone.

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.