Ranitidine EP Impurity K, PurCert

PurCert


Linear Formula:  C4H8N2O2S
Molecular Weight:  148.18 g/mol
CAS Number: 61832-41-5

Properties

Assay Purity >= 97 %
M pt. 112-118 °C
Density 1.199 ± 0.06 g/cm3
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 29309099
Storage Temp. 2-8 °C
Storage Class 11 - Combustible Solids
UN Number NA

Description

Application
Ranitidine EP Impurity K is used as a pharmaceutical reference standard for impurity profiling analytical method development 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 K in ranitidine in accordance with the specifications of the European Pharmacopoeia thereby ensuring product quality safety and regulatory compliance.

General Description
Ranitidine EP Impurity K 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 and quality of ranitidine-containing pharmaceutical products.