| CAS No. | CATO-C4X-204611 |
| Molecular Formula | 2*C19H19NOS |
| Molecular Weight | N/A |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Recommended for quantitative analysis by HPLC, GC, LC-MS/MS, or GC-MS as an external calibration standard; it can also be used for spiked-recovery experiments, LOD/LOQ determination, and LC-MS/MS multiple-reaction-monitoring (MRM) calibration.
CATO supplies Ketotifen Impurity 11 Hemifumarate (CAS CATO-C4X-204611), a pharmacopoeial impurity reference standard (molecular formula C19H19NOSC4H4O4, MW 425.50 g/mol) used for the identification and quantification of trace impurities in APIs.
The molecular framework of Ketotifen Impurity 11 Hemifumarate (C19H19NOSC4H4O4) is characterized by a flavonoid core, an amide group, a sulfone group, a hydroxyl group, an ether linkage. In reversed-phase chromatography, its retention is governed primarily by the protonation state of its nitrogen-containing groups, which provides a practical basis for HPLC-UV/DAD or LC-MS method development. The aromatic system may exhibit native fluorescence, enabling detection with a fluorescence detector (FLD).
As a certified reference material (CRM), Ketotifen Impurity 11 Hemifumarate meets the metrological traceability requirements of ISO/IEC 17025 laboratories. Batch-to-batch consistency is monitored via control charts to guarantee comparable assigned values across lots.
| Molecular Formula | 2*C19H19NOS C4H4O4 |
| Molecular Weight | 425.50 g/mol |
| Purity | 97%+ |
| Storage | Store at room temperature, protect from light, keep sealed and dry |
| Solubility (reference) | Soluble in methanol, acetonitrile, DMSO, water (slightly soluble) |
| Stability | May oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light |
| Degree of Unsaturation (DBE) | 13.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| Nitrogen Atoms | 1 |
| Sulfur Atoms | 1 |