Cromoglicate EP Impurity B CAS 16150-45-1
| CAS No. | 16150-45-1 |
| Molecular Formula | C27H24O11 |
| Molecular Weight | 524.47 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.
Cromoglicate EP Impurity B (CAS 16150-45-1) is a certified pharmaceutical impurity reference standard with the molecular formula C27H24O11 and a molecular weight of 524.47 g/mol.
The molecular framework of Cromoglicate EP Impurity B (C27H24O11) is characterized by a carboxylic acid group, a hydroxyl group, an ether linkage, a polycyclic aromatic system. In reversed-phase chromatography, its retention is governed primarily by the polarity and ionization state of its functional groups, 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).
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 | C27H24O11 |
| Molecular Weight | 524.47 g/mol |
| Appearance | Pale yellow to yellow crystalline powder |
| Purity | >95% |
| Storage | Store at room temperature, protect from light, keep sealed and dry |
| Solubility (reference) | Soluble in methanol, acetonitrile, DMSO, water (slightly soluble) |
| Stability | May oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light |
| Degree of Unsaturation (DBE) | 16.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 1961 |
Related Cromoglicate Standards
- Sodium Cromoglicate Impurity 15 (CAS 149992-30-3)
- Sodium Cromoglicate Impurity 23 (CAS CATO-C4X-201123)
- Sodium Cromoglicate Impurity 4 (CAS CATO-C4X-20114)
- Sodium Cromoglicate Impurity 21 (CAS CATO-C4X-201121)
- Sodium Cromoglicate Impurity 29 (CAS CATO-C4X-201129)
- Sodium Cromoglicate Impurity 11 (CAS 16110-51-3)
- Sodium Cromoglicate Impurity 3 (CAS CATO-C4X-20113)
- Sodium Cromoglicate Impurity 14 (CAS CATO-C4X-201114)
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