Milnacipran Impurity 13 CAS 19532-98-0
| CAS No. | 19532-98-0 |
| Molecular Formula | C10H12N2O2 |
| Molecular Weight | 192.21 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 Milnacipran Impurity 13.
Milnacipran Impurity 13 (CAS 19532-98-0) is a certified pharmaceutical impurity reference standard with the molecular formula C10H12N2O2 and a molecular weight of 192.21 g/mol.
The molecular framework of Milnacipran Impurity 13 (C10H12N2O2) is characterized by an amino-acid-derived structure, an amide group, a hydroxyl group, an ether linkage. In reversed-phase chromatography, its retention is governed primarily by its high hydrophobicity (logP), which provides a practical basis for HPLC-UV/DAD or LC-MS method development. Nitrogen-containing functional groups confer excellent ionization efficiency in positive-ion electrospray (ESI) mode, making the compound well suited to LC-MS/MS analysis.
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 | C10H12N2O2 |
| Molecular Weight | 192.21 g/mol |
| Appearance | Off-white to pale yellow crystalline powder. (faint amine-like odor) |
| Purity | 97%+ |
| Storage | Store at 2-8°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) | 6.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 1962 |
| Nitrogen Atoms | 2 |
Related Milnacipran Standards
- Milnacipran Impurity 1 (CAS 66823-04-9)
- Milnacipran impurity 34 (CAS CATO-C4X-103334)
- Milnacipran impurity 37 (CAS 96847-51-7)
- Milnacipran impurity 30 (CAS 115373-42-7)
- Milnacipran Impurity 16 (CAS 871100-19-5)
- Milnacipran Impurity 5 (CAS 1932365-99-5)
- Milnacipran Impurity N11 (CAS CATO-CP150468)
- Milnacipran Impurity 4 (CAS 64805-64-7)
Recommended Standards
- CAS 62780-92-1 (CAS 62780-92-1)
- (2E)-N-(2-Ethylphenyl)-2-(hydroxyimino)acetamide 7509-61-7 9193AE C10H12N2O2 (CAS 7509-61-7)
- 7501-09-9 Benzoic acid,4-methoxy-3-(2-propen-1-yl)- CTK5E0916 (CAS 7501-09-9)
- Donepezil EP impurity B (CAS 2107-69-9)
- Cefpodoxime Impurity 58 (CAS CATO-C4X-157958)
- Rosiglitazone Impurity 4 (CAS CATO-C4X-21794)
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- 2,6-Dichloro-4-fluoro-[1,1-biphenyl]-4-carbaldehyde (CAS 1350760-15-4)
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