Mexiletine EP Impurity A, PurCert
PurCert
Properties
| Autoignition temp. | 1110 °F |
| Assay Purity | >=95% |
| B pt. | 203 °C |
| M pt. | 43 - 45 °C |
| Density | 1.13 g/cm3 |
| Form | Solid |
Safety Information
| Hazard Statement(s) | H301 + H311,H314,H335,H411 |
| Precautionary Statement | P260 - P273 - P280 - P303 + P361 + P353 - P304 + P340 + P310 - P305 + P351 + P338 |
| GHS Pictogram |
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| Signal word | Danger |
| Flash point | 86 °C |
| Storage Temp. | 2-8 °C |
| Storage Class | 6.1A - Combustible acute toxic Cat. 1 and 2 / very toxic hazardous materials |
| UN Number | 2261 |
Description
Application
Mexiletine EP Impurity A is used as a pharmacopoeial reference standard in pharmaceutical quality control laboratories for the analysis of mexiletine active pharmaceutical ingredient (API) and finished dosage forms.
Purpose
The purpose of Mexiletine EP Impurity A is to identify quantify and control this specified impurity during analytical testing ensuring that mexiletine products comply with the impurity limits established by the European Pharmacopoeia (EP) and regulator
General Description
Mexiletine EP Impurity A is a specified related impurity of mexiletine that is described in the European Pharmacopoeia and provided as a certified reference material for use in validated analytical methods such as high-performance liquid chromatography (HPLC) for impurity profiling and quality assurance.
Documents
| SDS | |
| COA | |
| Specification | |
| Bulk quote order form | |
| Sample COA |
