Vonoprazan Fumarate Impurity 85(See C4X-102077) CAS CATO-C4X-102085
| CAS No. | CATO-C4X-102085 |
| Molecular Formula | C16H13ClFN3O2S |
| 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 Vonoprazan Fumarate Impurity 85(See C4X-102077).
As a process- or degradation-related impurity, Vonoprazan Fumarate Impurity 85(See C4X-102077) (CAS CATO-C4X-102085, C16H13ClFN3O2SC4H4O4) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
Structurally, Vonoprazan Fumarate Impurity 85(See C4X-102077) (C16H13ClFN3O2SC4H4O4) contains a flavonoid core, an amide group, a sulfone group, a hydroxyl group, an ether linkage, fluorine/chlorine substitution. The molecule exhibits a degree of unsaturation (DBE) of 13.0, corresponding to approximately 13 ring(s) or double-bond equivalent(s). With a molecular weight of 481.88 g/mol, it falls into the moderately-high-molecular-weight range. Halogen substitution (F/Cl/Br/I) produces a distinctive isotope pattern in mass spectrometry, a valuable aid for qualitative confirmation.
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.
The assigned purity is verified by mass-balance and quantitative NMR (qNMR) approaches, with the expanded uncertainty reported at a 95% confidence level (k=2). Batch homogeneity and stability are independently assessed for every lot.
Physical & Chemical Properties
| Molecular Formula | C16H13ClFN3O2S C4H4O4 |
| Molecular Weight | 481.88 g/mol |
| Purity | 97%+ |
| 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) | 13.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| Halogen Content | F/Cl-containing |
| Nitrogen Atoms | 3 |
| Sulfur Atoms | 1 |
Related Vonoprazan Standards
- Vonoprazan Impurity 298 (CAS 103860-56-6)
- Vonoprazan Impurity 82 (CAS 106058-86-0)
- Vonoprazan Fumarate Impurity 71 (CAS 1060802-18-7)
- Vonoprazan Impurity 129 (CAS 109-00-2)
- Vonoprazan Impurity 188 (CAS 111480-82-1)
- Vonoprazan Impurity 195 (CAS 1126403-28-8)
- Vonoprazan Impurity 10 (CAS 122453-85-4)
- Vonoprazan Impurity 89 (CAS 1224739-02-9)
Recommended Standards
- Pantoprazole Impurity 67 HCl (CAS CATO-C4X-139967)
- Roflumilast Impurity 7 (CAS 1391053-75-0)
- Amorolfine EP Impurity H HCl (CAS CATO-C4X-15429)
- Benzyl (3R,4R)-4-((tert-butoxycarbonyl)amino)-3-fluoropiperidine-1-carboxylate (CAS 1372857-83-4)
- Zinc(II) tetrakis(4-carboxyphenyl)porphine (CAS 27647-84-3)
- 5-(5-Chloro-2-methoxyphenyl)-4-ethyl-4H-1,2,4-triazole-3-thiol (CAS 369394-90-1)
- N-Cbz-6-oxa-3-azabicyclo[3.1.0]hexane (CAS 31865-25-5)
- tert-Butyl 4-(2-(5-cyanopyridin-3-yl)ethyl)piperazine-1-carboxylate (CAS 2602340-78-1)
- (E)-2-cyano-N-cyclohexyl-3-(3-hydroxyphenyl)acrylamide (CAS 351893-99-7)
- Liraglutide (CAS 204656-20-2)
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