Ranitidine EP Impurity F (Hydrochloride Salt), PurCert
PurCert
Properties
| Assay Purity | >=98% |
| M pt. | 122-125 °C |
| Form | Solid |
Safety Information
| Hazard Statement(s) | H315,H319,H335 |
| Precautionary Statement | P261 - P264 - P271 - P280 - P302 + P352 - P305 + P351 + P338 |
| GHS Pictogram |
|
| Signal word | Warning |
| HS Code | 29321990 |
| Storage Temp. | 2-8 °C |
| Storage Class | 11 - Combustible Solids |
| UN Number | NA |
Description
Application
Ranitidine EP Impurity F 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 facilitate the accurate identification and quantification of Impurity F in ranitidine according to the specifications of the European Pharmacopoeia thereby ensuring product quality safety and regulatory compliance.
General Description
Ranitidine EP Impurity F 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 |
