Quetiapine Impurity 35 CAS 329216-65-1
| CAS No. | 329216-65-1 |
| Molecular Formula | C21H25N3O4S |
| Molecular Weight | 415.51 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
Owing to a flavonoid core, an amide group, a sulfone group, a hydroxyl group, an ether linkage, Quetiapine Impurity 35 is typically pale yellow to yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 415.51 g/mol — guide the selection of appropriate sample preparation and analytical techniques. The aromatic system may exhibit native fluorescence, enabling detection with a fluorescence detector (FLD).
As a process- or degradation-related impurity, Quetiapine Impurity 35 (CAS 329216-65-1, C21H25N3O4S) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
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 | C21H25N3O4S |
| Molecular Weight | 415.51 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 |
| Degree of Unsaturation (DBE) | 11.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 2025 |
| Nitrogen Atoms | 3 |
| Sulfur Atoms | 1 |
Related Quetiapine Standards
- Quetiapine Impurity 51 (CAS 1185170-04-0)
- Quetiapine impurity 73 (CAS CATO-C4X-124473)
- Quetiapine EP Impurity L (CAS 1371638-11-7)
- Quetiapine Impurity N2 (CAS 2206135-50-2)
- Quetiapine EP Impurity A (CAS 844639-07-2)
- Quetiapine Carboxylate Impurity (CAS 1011758-00-1)
- Quetiapine Impurity N3 (CAS 102893-57-2)
- Quetiapine Impurity 4 (CAS 1241800-24-7)
Recommended Standards
- Carbamazepine Impurity 6 (CAS 40421-03-2)
- Tert-butyl 4-(3-benzamidothiophene-2-carbonyl)piperazine-1-carboxylate (CAS 692738-33-3)
- sabeluzole (CAS 104383-17-7)
- N-Benzyl-5-methanesulfonyl-N,2-diphenylpyrimidin-4-amine (CAS 478080-89-6)
- Sodium aminosalicylate Impurity 4 (CAS 17540-51-1)
- Mirabegron Impurity 35 (CAS CATO-C4X-103235)
- Capivasertib Impurity 45 (CAS CATO-C4X-331245)
- 1-(Bromomethyl)-4-methyl-1-(2-propoxyethoxy)cyclohexane (CAS 1339451-99-8)
- 2-Cyclopropanecarbonyl-4-ethylphenol (CAS 847344-89-2)
- Methyl 2-hydroxy-5-iodo-4-(trifluoromethyl)benzoate (CAS 1131587-48-8)
- (3-((Tetrahydro-2h-pyran-2-yl)methoxy)phenyl)boronic acid (CAS 1311185-12-2)
- 1-[3-(Methylsulfanyl)phenyl]imidazolidin-2-one (CAS 14089-00-0)
- 4-(2-Methyl-1h-imidazol-1-yl)-2-(methylamino)butanamide (CAS 1341525-25-4)
- Semaglutide Impurity 148 (CAS CATO-C4X-2226148)
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