Roxatidine Impurity 35 Hydrochloride CAS CATO-C4X-121335
| CAS No. | CATO-C4X-121335 |
| Molecular Formula | C32H48N4O3 |
| Molecular Weight | N/A |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
Under current pharmacopoeial and regulatory frameworks, quality-control requirements for this class of reference material explicitly involve the control of targets including Roxatidine Impurity 35 Hydrochloride.
CATO supplies Roxatidine Impurity 35 Hydrochloride (CAS CATO-C4X-121335), a pharmacopoeial impurity reference standard (molecular formula C32H48N4O3HCl, MW 573.22 g/mol) used for the identification and quantification of trace impurities in APIs.
The molecular framework of Roxatidine Impurity 35 Hydrochloride (C32H48N4O3HCl) is characterized by a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage, chlorine substitution. 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).
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.
As a certified reference material (CRM), Roxatidine Impurity 35 Hydrochloride 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.
Physical & Chemical Properties
| Molecular Formula | C32H48N4O3 HCl |
| Molecular Weight | 573.22 g/mol |
| Appearance | Pale yellow to yellow crystalline powder. (slight halide-like odor) |
| 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) | 10.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| Halogen Content | Cl-containing |
| Nitrogen Atoms | 4 |
Related Roxatidine Standards
- Roxatidine Impurity 43 (CAS 100-83-4)
- Roxatidine Impurity 55 (CAS 100841-00-7)
- Roxatidine Impurity 21 (CAS 108441-34-5)
- Roxatidine Hemioxalate (CAS 110925-92-3)
- Roxatidine Impurity 58 (CAS 115062-97-0)
- Roxatidine Impurity 56 (CAS 132513-51-0)
- Roxatidine Impurity 34 (CAS 15504-60-6)
- Roxatidine Impurity 3 (CAS 195621-06-8)
Recommended Standards
- Roxadustat Impurity 18 (CAS 2376195-48-9)
- Letermovir Impurity 105 (CAS CATO-C4X-2915105)
- Nifuroxazide EP Impurity E (CAS CATO-C4X-21533)
- 4-Acetamido-2-(chlorosulfonyl)phenyl acetate (CAS 858240-83-2)
- 1-(3-(1,1-Difluoro-2-methoxyethyl)-2-fluorophenyl)ethan-1-one (CAS 2688115-54-8)
- 1,3-Diphenyl-2-(thiophen-2-yl)imidazolidine (CAS 102174-92-5)
- 3-(Piperidin-4-yl)-1h-1,2,4-triazol-5-amine (CAS 1250823-11-0)
- Cobalt(II) Acetate (CAS 944155-28-6)
- Butenafine Impurity 12 (CAS 88-03-9)
- Semaglutide Impurity 10 (CAS CATO-C4X-222610)
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