Norethisterone EP Impurity F CAS 96487-85-3
| CAS No. | 96487-85-3 |
| Molecular Formula | C22H30O2 |
| Molecular Weight | 326.47 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 Norethisterone EP Impurity F.
CATO supplies Norethisterone EP Impurity F (CAS 96487-85-3), a pharmacopoeial impurity reference standard (molecular formula C22H30O2, MW 326.47 g/mol) used for the identification and quantification of trace impurities in APIs.
Structurally, Norethisterone EP Impurity F (C22H30O2) contains a steroid core, a hydroxyl group, an ether linkage. The molecule exhibits a degree of unsaturation (DBE) of 8.0, corresponding to approximately 8 ring(s) or double-bond equivalent(s). With a molecular weight of 326.47 g/mol, it falls into the moderately-high-molecular-weight range. 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).
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 | C22H30O2 |
| Molecular Weight | 326.47 g/mol |
| Appearance | Pale yellow to 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) | 8.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 1984 |
Related Norethisterone Standards
- Norethisterone EP Impurity H (CAS 51724-44-8)
- Norethisterone Acetate (CAS 51-98-9)
- Norethisterone Acetate EP Impurity C (CAS 1175129-26-6)
- Norethisterone Acetate EP Impurity B (CAS 19637-28-6)
- Norethisterone EP Impurity E (CAS 79727-03-0)
- Norethisterone Acetate EP Impurity G (CAS 438244-27-0)
- Norethisterone EP Impurity G (CAS 38673-36-8)
- Norethisterone EP Impurity D (CAS 68-23-5)
Recommended Standards
- Levonorgestrel EP Impurity T (CAS 14507-51-8)
- Oseltamivir Impurity 185 (CAS CATO-C4X-1720185)
- Levonorgestrel EP Impurity S (CAS 176254-10-7)
- Bempedoic Acid Impurity 51 (CAS 2127387-65-7)
- Revefenacin Impurity 6 (CAS CATO-C4X-20316)
- Phenytoin EP Impurity E (CAS 6802-95-5)
- Fluvoxamine impurity 45 (CAS CATO-C4X-195145)
- 7,8-Dihydro-a-methyl-N-[3-[3-(trifluoromethyl)phenyl]propyl]-1-naphthalenemethanamine Hydrochloride (CAS 1622173-72-1)
- 2-ethynyloxolane (CAS 76928-54-6)
- Trenbolone (CAS 10161-33-8)
- (2S,3R,4R,5S,6S)-2-methyl-6-(2,2,2-trichloro-1-iminoethoxy)tetrahydro-2H-pyran-3,4,5-triyl triacetate (CAS 128571-86-8)
- Edoxaban Impurity 121 (CAS CATO-C4X-1063121)
- (4-(5-Chloro-2-methoxyphenyl)tetrahydro-2H-pyran-4-yl)methanamine (CAS 1152568-61-0)
- Myristoyl Pentapeptide-4 (CAS 1392416-25-9)
Why CATO?
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