Ranitidine EP Impurity H, PurCert
PurCert
Synonym: N-Methyl-2-nitroacetamide
Linear Formula:
C3H6N2O3
Molecular Weight: 118.09 g/mol
CAS Number: 72078-82-1
Properties
| Assay Purity | >=90% |
| B pt. | 325.3 °C |
| M pt. | 68 °C |
| Form | Solid |
Safety Information
| GHS Pictogram | |
| HS Code | 29241990 |
| Storage Temp. | 2-8 °C |
| Storage Class | 11 - Combustible Solids |
| UN Number | NA |
Description
Application
Ranitidine EP Impurity H is used as a pharmaceutical reference standard for impurity profiling analytical method development method validation stability studies and routine quality control testing of ranitidine drug substances and finished pharmaceutical products.
Purpose
Its primary purpose is to enable the accurate identification and quantification of Impurity H in ranitidine in accordance with the specifications of the European Pharmacopoeia thereby ensuring product quality safety and regulatory compliance.
General Description
Ranitidine EP Impurity H is a specified ranitidine-related impurity listed in the European Pharmacopoeia and supplied as a certified reference standard for use in chromatographic and other analytical methods to assess the purity stability and overall quality of ranitidine-containing pharmaceutical products.
Documents
| SDS | |
| COA | |
| Specification | |
| Bulk quote order form | |
| Sample COA |
