Prednisone Impurity 8 CAS CATO-C4X-16948
| CAS No. | CATO-C4X-16948 |
| Molecular Formula | C21H29O8P |
| Molecular Weight | 440.42 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
As a process- or degradation-related impurity, Prednisone Impurity 8 (CAS CATO-C4X-16948, C21H29O8P) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
Structurally, Prednisone Impurity 8 (C21H29O8P) contains a flavonoid core, a phosphate ester group, a hydroxyl group, an ether linkage. The molecule exhibits a degree of unsaturation (DBE) of 7.5, corresponding to approximately 7 ring(s) or double-bond equivalent(s). With a molecular weight of 440.42 g/mol, it falls into the moderately-high-molecular-weight range. 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 | C21H29O8P |
| Molecular Weight | 440.42 g/mol |
| Appearance | Off-white to pale yellow crystalline powder |
| Purity | 97%+ |
| 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) | 7.5 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
Related Prednisone Standards
- Prednisone Impurity 13 (CAS 97830-94-9)
- Prednisone Impurity 9 (CAS 2435-02-1)
- Prednisone 21-Acetate (CAS 125-10-0)
- Prednisone Impurity 11 (CAS 2601-23-2)
- Prednisone-d4 (Major) (CAS CATO-C4X-191925)
- Prednisone Impurity N297 (CAS 1249-67-8)
- Prednisone Impurity 14 (CAS CATO-C4X-169414)
- Prednisone Impurity N56 (CAS 103466-44-0)
Recommended Standards
- Prednisolone Phosphate - API Standards (CAS 302-25-0)
- Prednisolone Impurity 20 (CAS CATO-C4X-173720)
- Cortisone Phosphate (CAS 508-95-2)
- Prednisolone Impurity 21 (CAS CATO-C4X-173721)
- Flucloxacillin impurity 14 (CAS CATO-C4X-164714)
- Mosapride impurity 44 (CAS CATO-C4X-104459)
- Vinpocetine Impurity 1 (CAS 77549-94-1)
- 2-(4-Amino-2-(trifluoromethyl)phenyl)acetonitrile (CAS 1824663-54-8)
- 3-(4-Bromo-3-fluorobenzoyl)thiophene (CAS 898771-15-8)
- 5-Bromo-6-fluoro-2-methylquinoline (CAS 80290-18-2)
- (1-(2-Hydroxyethyl)-3-phenyl-1H-pyrazolo[3,4-b]pyridin-5-yl)(2-hydroxyphenyl)methanone (CAS 796053-09-3)
- 4-Bromo-2-chloro-5-fluorobenzenethiol (CAS 1208077-01-3)
- N,N-dimethyl-4-(piperazin-1-yl)aniline (CAS 91703-23-0)
- Mast Cell Degranulating Peptide HR-1 (CAS 80533-94-4)
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