Ranitidine EP Impurity B (2HCl), PurCert

PurCert


Properties

Assay Purity >=95%
Form Solid

Safety Information

Hazard Statement(s) H302-H315-H319-H335
Precautionary Statement  P261-P280-P301+P312-P302+P352-P305+P351+P338
GHS Pictogram
Signal word Warning
Storage Temp. 2-8 °C
UN Number NA

Description

Application
Ranitidine EP Impurity B (2HCl) is used as a pharmaceutical reference standard for impurity profiling analytical method validation 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 B in ranitidine according to the specifications of the European Pharmacopoeia ensuring product quality safety and regulatory compliance.

General Description
Ranitidine EP Impurity B (2HCl) is the dihydrochloride salt form of a specified ranitidine-related impurity provided as a certified European Pharmacopoeia reference standard for use in chromatographic and other analytical procedures to assess the purity of ranitidine-containing pharmaceuticals.