Ranitidine EP Impurity F (Hydrochloride Salt), PurCert

PurCert


Linear Formula:  C8H14ClNO2
Molecular Weight:  191.66 g/mol
CAS Number: 81074-81-9

Properties

Assay Purity >=98%
M pt. 122-125 °C
Form Solid

Safety Information

Hazard Statement(s) H315,H319,H335
Precautionary Statement  P261 - P264 - P271 - P280 - P302 + P352 - P305 + P351 + P338
GHS Pictogram
Signal word Warning
HS Code 29321990
Storage Temp. 2-8 °C
Storage Class 11 - Combustible Solids
UN Number NA

Description

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

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

General Description
Ranitidine EP Impurity F 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 assess the purity stability and overall quality of ranitidine-containing pharmaceutical products.