Isotretinoin EP Impurity A Sodium salt CAS 13497-05-7
| CAS No. | 13497-05-7 |
| Molecular Formula | C20H28O2 |
| Molecular Weight | N/A |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
CATO manufactures Isotretinoin EP Impurity A Sodium salt under ISO 17034:2016 accreditation with dual CNAS and ANAB accreditation. Each batch is characterized by orthogonal methods and supplied with a full Certificate of Analysis (COA), ensuring metrological traceability.
As a process- or degradation-related impurity, Isotretinoin EP Impurity A Sodium salt (CAS 13497-05-7, C20H28O2Na) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
Isotretinoin EP Impurity A Sodium salt (C20H28O2Na) contains a steroid core, a hydroxyl group, an ether linkage. Its high carbon-to-hydrogen ratio confers good lipid solubility, the carboxyl group imparts weak acidity; these physicochemical properties determine the optimal preparation and storage of its standard solutions. 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.
Physical & Chemical Properties
| Molecular Formula | C20H28O2 Na |
| Molecular Weight | 323.43 g/mol |
| Appearance | Off-white to pale 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) | 7.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 1960 |
Related Isotretinoin Standards
- Isotretinoin Impurity 11 (CAS 14398-42-6)
- Isotretinoin (CAS 4759-48-2)
- Isotretinoin EP Impurity D (CAS 5300-03-8)
- Isotretinoin EP Impurity F (CAS 68070-35-9)
- Isotretinoin EP Impurity H (CAS 71748-58-8)
- Isotretinoin EP Impurity I (CAS 75281-25-3)
- Isotretinoin Glucuronide (CAS 78147-42-9)
- Isotretinoin EP Impurity G (5,6-Epoxy-13-cis Retinoic Acid) (and enantiomer) (CAS 81444-57-7)
Recommended Standards
- Lusutrombopag Impurity 58 (CAS CATO-C4X-208458)
- Cinnarizine impurity 01 (CAS 95062-18-3)
- Amisulpride Impurity 41 (CAS 2230058-95-2)
- N-(7-Fluoroquinoxalin-6-yl)acetamide (CAS 920034-11-3)
- 4-Bromo-5-ethoxypyrrolidin-2-one (CAS 341008-61-5)
- 5-Bromo-1-methyl-3H-1,2-benzothiazole 1-oxide (CAS 2649070-11-9)
- Ethyl 3-(4,4,5,5-tetramethyl-1,3,2-dioxaborolan-2-yl)propanoate (CAS 302577-73-7)
- Ibuprofen Impurity 116 (CAS CATO-C4X-1082116)
- N,N-diethyl-1H-pyrazole-4-carboxamide (CAS 1153845-34-1)
- D-Phe22-Tirzepatide (CAS CATO-CPTD788912)
Why CATO?
- ISO 17034 accredited reference material producer (CNAS + ANAB dual accreditation)
- 130,000+ catalog items in stock, COA supplied with every batch
- Worldwide shipping with full export documentation (HS code guidance available)
- Technical support: +86 18665070610 / Nicole.chen@cato-chem.com