Atropine Impurity 53 CAS CATO-C4X-148953
| CAS No. | CATO-C4X-148953 |
| Molecular Formula | C17H23NO4 |
| Molecular Weight | 305.37 g/mol |
| 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 Atropine Impurity 53.
As a process- or degradation-related impurity, Atropine Impurity 53 (CAS CATO-C4X-148953, C17H23NO4) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
Structurally, Atropine Impurity 53 (C17H23NO4) contains a flavonoid core, an amide group, a hydroxyl group, an ether linkage. The molecule exhibits a degree of unsaturation (DBE) of 7.0, corresponding to approximately 7 ring(s) or double-bond equivalent(s). With a molecular weight of 305.37 g/mol, it falls into the moderately-high-molecular-weight range. 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.
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 | C17H23NO4 |
| Molecular Weight | 305.37 g/mol |
| Appearance | Off-white to pale yellow crystalline powder |
| Purity | >95% |
| Storage | Store at 2-8°C, 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) | 7.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| Nitrogen Atoms | 1 |
Related Atropine Standards
- Atropine EP Impurity E(7-Hydroxyhyoscyamine) (CAS 949092-65-3)
- Atropine EP Impurity D(6-hydroxyhyoscyamine) (CAS CATO-C4X-148914)
- Atropine Impurity 32 (CAS 4438-22-6)
- Atropine Sulfate EP Impurity D (CAS CATO-C4X-148939)
- Atropine N-Oxide (CAS CATO-C4X-148941)
- Atropine Impurity 49 (CAS CATO-C4X-148949)
- Atropine Impurity 50 (CAS CATO-C4X-148950)
- Atropine Impurity 51 (CAS CATO-C4X-148951)
Recommended Standards
- Tiotropium impurity 50 (CAS CATO-C4X-176450)
- Imidafenacin Impurity 1 (CAS 170105-20-1)
- Epalrestat Impurity 17 (CAS 1800597-47-0)
- Upadacitinib Impurity 184 (CAS 2306245-20-3)
- Ertapenem Impurity 26 (CAS CATO-C4X-163326)
- Ubrogepant Impurity 2 (CAS CATO-C4X-34022)
- Benzylpenicillin Impurity 29 (CAS 58678-43-6)
- 5-Bromo-4,6-difluoro-2,3-dihydro-1H-indol-2-one (CAS 1857381-07-7)
- 3-Bromo-5-(chloromethyl)-1-methyl-1H-pyrazole (CAS 2109428-60-4)
- 5-Hydroxy-2-methylbenzoxazole (CAS 23997-94-6)
- Gypenoside XVII (CAS 80321-69-3)
- 2,3,6-Trifluoroaniline (CAS 67815-56-9)
- 5,12-Dibutyl-1,3,8,10-tetramethylquinacridone (CAS 850815-10-0)
- Semaglutide impurity 77 (CAS CATO-C4X-222677)
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