Isotretinoin EP Impurity H CAS 71748-58-8
| CAS No. | 71748-58-8 |
| Molecular Formula | C20H26O3 |
| Molecular Weight | 314.42 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
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 process- or degradation-related impurity, Isotretinoin EP Impurity H (CAS 71748-58-8, C20H26O3) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
Owing to a steroid core, a hydroxyl group, an ether linkage, Isotretinoin EP Impurity H is typically pale yellow to yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 314.42 g/mol — guide the selection of appropriate sample preparation and analytical techniques. The high carbon-to-hydrogen ratio imparts good lipophilicity, allowing liquid-liquid extraction with non-polar solvents such as n-hexane or ethyl acetate.
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 | C20H26O3 |
| Molecular Weight | 314.42 g/mol |
| Appearance | Pale yellow to yellow crystalline powder |
| Purity | >95% |
| Storage | Store at 2-8°C, protect from light, keep sealed and dry |
| 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.) | 1977 |
Related Isotretinoin Standards
- Isotretinoin EP Impurity G (5,6-Epoxy-13-cis Retinoic Acid) (and enantiomer) (CAS 81444-57-7)
- Isotretinoin EP Impurity I (CAS 75281-25-3)
- Isotretinoin-d5 (CAS CATO-C4X-196936)
- Isotretinoin EP Impurity F (CAS 68070-35-9)
- Isotretinoin EP Impurity D (CAS 5300-03-8)
- Isotretinoin (CAS 4759-48-2)
- Isotretinoin Impurity 11 (CAS 14398-42-6)
- Isotretinoin Glucuronide (CAS 78147-42-9)
Recommended Standards
- 4-Oxo Tretinoin (4-Oxo Retinoic Acid) (CAS 38030-57-8)
- Brivaracetam Impurity 75 (CAS CATO-C4X-200775)
- Methylprednisolone EP Impurity C (CAS 61919-52-6)
- Brivaracetam Impurity 91 (CAS CATO-C4X-200791)
- Maxacalcitol Impurity 17 (CAS 147725-62-0)
- Simvastatin EP Impurity I (CAS 79902-42-4)
- Prostaglandin Impurity 24 (CAS CATO-C4X-199624)
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- 4-chloro-2-(1,3-thiazol-2-yl)pyrimidine (CAS 1564749-78-5)
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- 1,1,2-Triethoxyethane (CAS 4819-77-6)
- Adrenal Peptide E, bovine (CAS 78355-50-7)
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