Levonorgestrel EP Impurity N CAS 4222-96-2
| CAS No. | 4222-96-2 |
| Molecular Formula | C19H26O2 |
| Molecular Weight | 286.41 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
The occurrence of Levonorgestrel EP Impurity N is closely related to a steroid core, a hydroxyl group, an ether linkage in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.
CATO supplies Levonorgestrel EP Impurity N (CAS 4222-96-2), a pharmacopoeial impurity reference standard (molecular formula C19H26O2, MW 286.41 g/mol) used for the identification and quantification of trace impurities in APIs.
The molecular framework of Levonorgestrel EP Impurity N (C19H26O2) is characterized by a steroid core, 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. The high carbon-to-hydrogen ratio imparts good lipophilicity, allowing liquid-liquid extraction with non-polar solvents such as n-hexane or ethyl acetate.
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), Levonorgestrel EP Impurity N 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 | C19H26O2 |
| Molecular Weight | 286.41 g/mol |
| Appearance | Off-white to pale yellow crystalline powder |
| Purity | >95% |
| Storage | Store at 2-8°C, protect from light |
| Solubility (reference) | Soluble in chloroform, dichloromethane, ethyl acetate, DMSO |
| 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 |
| CAS Registry Year (est.) | 1958 |
Related Levonorgestrel Standards
- Levonorgestrel EP Impurity L (CAS 21800-83-9)
- Levonorgestrel Impurity 35 (CAS 300542-76-1)
- Levonorgestrel EP Impurity K (CAS 793-55-5)
- Levonorgestrel Impurity 34 (CAS CATO-C4X-167734)
- Levonorgestrel Impurity N1 (CAS 7443-72-3)
- Levonorgestrel Impurity 4 (Ethylmetrienone) (CAS 848-04-4)
- Levonorgestrel EP Impurity D (CAS 32419-58-2)
- Levonorgestrel EP Impurity R (CAS 2322-77-2)
Recommended Standards
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- Gadoteridol impurity 40 (CAS 137145-75-6)
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- Gatifloxacin Impurity 13 (CAS 103460-87-3)
- Obeticholic Acid Impurity 49 (CAS 2410049-27-1)
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