| CAS No. | 1026015-45-1 (free base) |
| Molecular Formula | C22H22FN3O2 |
| Molecular Weight | N/A |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Under current pharmacopoeial and regulatory frameworks, quality-control requirements for this class of reference material explicitly involve the control of targets including Droperidol EP Impurity B HCl.
CATO supplies Droperidol EP Impurity B HCl (CAS 1026015-45-1 (free base)), a pharmacopoeial impurity reference standard (molecular formula C22H22FN3O2HCl, MW 415.89 g/mol) used for the identification and quantification of trace impurities in APIs.
Based on its molecular formula C22H22FN3O2HCl, Droperidol EP Impurity B HCl contains a steroid core, an amide group, a hydroxyl group, an ether linkage, fluorine/chlorine substitution; these features give the compound characteristic absorption bands in UV spectroscopy. The molecular weight of 415.89 g/mol is directly relevant to the identification of the molecular ion in mass spectrometry. The presence of an aromatic ring or conjugated system gives the compound characteristic absorption bands in the UV-Vis region, making it well suited to UV or diode-array detection (DAD).
This reference standard supports related-substances testing and method development in line with ICH Q3A/Q3B guidance on impurity control, and is suitable for system suitability testing and forced-degradation studies.
CATO manufactures Droperidol EP Impurity B HCl under ISO 17034:2016 accreditation with dual CNAS and ANAB accreditation. Each batch is characterized by orthogonal methods and supplied with a full Certificate of Analysis (COA), ensuring metrological traceability.
| Molecular Formula | C22H22FN3O2 HCl |
| Molecular Weight | 415.89 g/mol |
| Appearance | Pale yellow to yellow crystalline powder. (slight halide-like odor, low volatility) |
| Purity | >95% |
| Storage | Store in a cool place (≤25°C), protect from light, keep sealed and dry |
| Solubility (reference) | Soluble in DMSO, DMF, methanol |
| Stability | May oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light; Hygroscopic; reseal immediately after opening; Contains ester bond; hydrolyzes under strong alkaline conditions |
| Degree of Unsaturation (DBE) | 12.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| Halogen Content | F/Cl-containing |
| Nitrogen Atoms | 3 |