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.
Documents
| SDS | |
| COA | |
| Specification | |
| Bulk quote order form | |
| Sample COA |
