Glycopyrronium Bromide EP Impurity J, PurCert
PurCert
Properties
| Assay Purity | >= 95 % |
| M pt. | 146-151 °C |
| Density | 1.247 ± 0.06 g/cm3 |
| Form | Solid |
Safety Information
| Hazard Statement(s) | H318 |
| Precautionary Statement | P280 - P305 + P351 + P338 |
| GHS Pictogram |
|
| Signal word | Danger |
| HS Code | 29181990 |
| Storage Temp. | 2-8°C |
| Storage Class | 13 - Non Combustible Solids |
| UN Number | NA |
Description
Application
Glycopyrronium Bromide EP Impurity J is used in analytical method development method validation stability studies forced degradation studies regulatory submissions (such as ANDA filings) and routine pharmaceutical quality control of glycopyrronium bromide products
Purpose
The purpose of Glycopyrronium Bromide EP Impurity J is to serve as a certified reference impurity standard for identifying monitoring and quantifying impurity levels in glycopyrronium bromide drug substances and pharmaceutical formulations during qualit
General Description
Glycopyrronium Bromide EP Impurity J is a specified European Pharmacopoeia impurity of glycopyrronium bromide chemically identified as (2RS)-2-cyclopentyl-2-hydroxy-2-phenylacetic acid .
Documents
| SDS | |
| COA | |
| Specification | |
| Bulk quote order form | |
| Sample COA |