Sorafenib Impurity H, PurCert

PurCert


Properties

Water Solubility at 20 °C at 1.013 hPa slightly soluble
Assay Purity >=98.5%
Form Solid

Safety Information

Hazard Statement(s) H360FD,H362,H372,H410
Precautionary Statement  P202 - P260 - P263 - P264 - P273 - P308 + P313
GHS Pictogram
Signal word Danger
HS Code 29339900
Storage Temp. 2-8 °C
Storage Class 6.1C - Combustible acute toxic Cat.3 / toxic compounds or compounds which causing chronic effects
UN Number 3077

Description

Application
Sorafenib Impurity H is primarily used as a reference standard in the pharmaceutical industry for the analysis and quality control of sorafenib drug substances and finished products.

Purpose
Its purpose is to identify monitor and quantify this specific impurity during the manufacturing process to ensure that sorafenib meets regulatory and quality specifications.

General Description
Sorafenib Impurity H is a process- or degradation-related impurity associated with sorafenib that is characterized and controlled using analytical techniques such as HPLC LC-MS and NMR to support drug safety stability and regulatory compliance.