Ibuprofen EP Impurity J CAS 65813-55-0
| CAS No. | 65813-55-0 |
| Molecular Formula | C13H16O3 |
| Molecular Weight | 220.26 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 Ibuprofen EP Impurity J.
Ibuprofen EP Impurity J (CAS 65813-55-0) is a certified pharmaceutical impurity reference standard with the molecular formula C13H16O3 and a molecular weight of 220.26 g/mol.
The molecular framework of Ibuprofen EP Impurity J (C13H16O3) is characterized by a carboxylic acid group, a hydroxyl group, an ether linkage, an aromatic ring system. 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 aromatic system may exhibit native fluorescence, enabling detection with a fluorescence detector (FLD).
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 | C13H16O3 |
| Molecular Weight | 220.26 g/mol |
| Appearance | Off-white to pale yellow crystalline powder |
| Purity | >90% |
| 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; Hygroscopic; reseal immediately after opening |
| Degree of Unsaturation (DBE) | 6.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 1975 |
Related Ibuprofen Standards
- Ibuprofen EP Impurity J (CAS CATO-C4X-1082148)
- Ibuprofen Impurity 53 (CAS CATO-C4X-108253)
- Ibuprofen Methyl Ester (CAS 61566-34-5)
- Ibuprofen EP Impurity L (CAS 53949-53-4)
- Ibuprofen EP Impurity M (CAS 60057-62-7)
- Ibuprofen Impurity 27 (CAS 53949-54-5)
- (S)-(+)-Ibuprofen Acid Chloride (CAS 115588-20-0)
- Ibuprofen Impurity 58 (CAS 80336-66-9)
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