Ranitidine EP Impurity J, PurCert

PurCert


Properties

Assay Purity >=90%
B pt. 572.6 °C
Density 1.28 g/cm3 at 20 °C
Form Solid

Safety Information

GHS Pictogram
HS Code 29309099
Storage Temp. 2-8 °C
Storage Class 11 - Combustible Solids
UN Number NA

Description

Application
Ranitidine EP Impurity J is used as a pharmaceutical reference standard for impurity profiling analytical method development method validation stability studies and quality control testing of ranitidine drug substances and finished pharmaceutical products.

Purpose
Its primary purpose is to enable the accurate identification and quantification of Impurity J in ranitidine according to the specifications of the European Pharmacopoeia ensuring product quality safety and regulatory compliance.

General Description
Ranitidine EP Impurity J is a specified ranitidine-related impurity listed in the European Pharmacopoeia and supplied as a certified reference standard for use in chromatographic and other analytical methods to evaluate the purity and quality of ranitidine-containing pharmaceutical products.