Norethisterone EP Impurity A CAS 31528-46-8
| CAS No. | 31528-46-8 |
| Molecular Formula | C20H24O2 |
| Molecular Weight | 296.40 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
The molecular framework of Norethisterone EP Impurity A (C20H24O2) 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 presence of an aromatic ring or conjugated system gives the compound characteristic absorption bands in the UV-Vis region, making it well suited to UV or diode-array detection (DAD).
As a process- or degradation-related impurity, Norethisterone EP Impurity A (CAS 31528-46-8, C20H24O2) 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 | C20H24O2 |
| Molecular Weight | 296.40 g/mol |
| Appearance | Pale yellow to yellow crystalline powder |
| Purity | 97%+ |
| 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) | 9.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 1966 |
Related Norethisterone Standards
- Norethisterone EP Impurity G (CAS 38673-36-8)
- Norethisterone EP Impurity D (CAS 68-23-5)
- Norethisterone EP Impurity C (CAS 22933-71-7)
- Norethisterone EP Impurity E (CAS 79727-03-0)
- Norethisterone EP Impurity H (CAS 51724-44-8)
- Norethisterone EP Impurity F (CAS 96487-85-3)
- Norethisterone Acetate (CAS 51-98-9)
- Norethisterone Acetate EP Impurity C (CAS 1175129-26-6)
Recommended Standards
- Exemestane Impurity 25 (CAS 2467590-81-2)
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- Betamethasone EP Impurity C (CAS 13504-15-9)
- Alectinib Impurity 44 (CAS CATO-C4X-283644)
- Pemafibrate Impurity 88 (CAS CATO-C4X-290388)
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