Azithromycin EP Impurity J, PurCert
PurCert
Properties
| Assay Purity | >=95% |
| M pt. | NA |
| Form | Solid |
Safety Information
| Hazard Statement(s) | NA |
| Precautionary Statement | NA |
| GHS Pictogram | |
| Signal word | NA |
| HS Code | NA |
| Storage Temp. | 2-8°C |
| Storage Class | 11 - Combustible Solids |
| UN Number | NA |
Description
Application
It is used as a reference standard in analytical methods (such as HPLCUPLC) to identify and quantify impurity J in azithromycin API and formulations.
Purpose
Its purpose is to support quality control and regulatory compliance ensuring impurity levels are within acceptable limits to maintain drug safety purity and stability.
General Description
Azithromycin EP Impurity J is a designated related substance listed in the European Pharmacopoeia for the antibiotic Azithromycin. It usually arises as a process-related or degradation impurity during manufacturing or upon storage.
Documents
| SDS | |
| COA | |
| Specification | |
| Bulk quote order form | |
| Sample COA |