25-Desacetyl-27-demethyl Rifampicin Impurity PurCert [Includes all characterization data]

PurCert


Properties

Assay Purity >= 96 %
Form Solid

Safety Information

Hazard Statement(s) H302-H412
Precautionary Statement  P264-P270-P273-P301+P312+P330-P501
GHS Pictogram
Storage Temp. 2-8 ?C

Description

Application
It serves as a certified reference material for HPLC method validation stability testing and quality control during Rifampicin (anti-TB drug) production particularly for ANDA submissions

Purpose
Its primary purpose is analytical impurity profiling to ensure Rifampicin purity complies with regulatory limits (0.5% total impurities) aiding detection via chromatography

General Description
25-Desacetyl-27-demethyl Rifampicin (CHNO) is a Rifampicin impurity and degradation product lacking both the 25-acetyl group and 27-methyl group from the parent antibiotic rifampicin appearing as a solid used as a reference standard in pharmaceutical analysis with molecular weight 766.90 gmol.