Prednisolone EP Impurity D CAS 16355-29-6
| CAS No. | 16355-29-6 |
| Molecular Formula | C21H28O6 |
| Molecular Weight | 376.44 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
Based on its molecular formula C21H28O6, Prednisolone EP Impurity D contains a flavonoid core, a hydroxyl group, an ether linkage; these features give the compound characteristic absorption bands in UV spectroscopy. The molecular weight of 376.44 g/mol is directly relevant to the identification of the molecular ion in mass spectrometry. The aromatic system may exhibit native fluorescence, enabling detection with a fluorescence detector (FLD).
As a process- or degradation-related impurity, Prednisolone EP Impurity D (CAS 16355-29-6, C21H28O6) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
Recommended for quantitative analysis by HPLC, GC, LC-MS/MS, or GC-MS as an external calibration standard; it can also be used for spiked-recovery experiments, LOD/LOQ determination, and LC-MS/MS multiple-reaction-monitoring (MRM) calibration.
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 | C21H28O6 |
| Molecular Weight | 376.44 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 methanol, acetonitrile, DMSO, water (slightly soluble) |
| 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.) | 1961 |
Related Prednisolone Standards
- Prednisolone EP Impurity E (CAS 95815-58-0)
- 6α-Methyl Prednisolone-d3 (CAS CATO-C4X-173725)
- Prednisolone Impurity 19 (CAS 61549-70-0)
- Prednisolone impurity 59 (CAS CATO-C4X-173759)
- Prednisolone-d8 (Major) (CAS CATO-C4X-191924)
- Prednisolone-d8 (CAS CATO-CCAD302219)
- Prednisolone-d8 (CAS CATO-LCAD302219-ME)
- Prednisolone Acetate EP Impurity E (CAS 4380-55-6)
Recommended Standards
- Budesonide Impurity 80 (CAS CATO-C4X-138980)
- Budesonide impurity 59 (CAS 34647-56-8)
- Mycophenolic Acid Impurity 9 (CAS CATO-C4X-21229)
- Budesonide impurity 41 (CAS CATO-C4X-138941)
- Biotin Impurity 36 (CAS 1535184-53-2)
- Clindamycin Impurity 73 (CAS 1123211-66-4 (free base))
- Bromfenac Impurity 14 (CAS CATO-C4X-200214)
- 3-Cyclopropoxy-6-isopropylpyridin-2-amine (CAS 1243376-71-7)
- Methyl 2-amino-4-(pyridin-2-yl)butanoate (CAS 1341582-24-8)
- N-(cyclopropyl(4-nitrophenyl)-lambda4-sulfanylidene)-2,2,2-trifluoroacetamide (CAS 1365543-59-4)
- Ethyl 2-methyl-3-oxo-4-phenylbutanoate (CAS 2867-62-1)
- 3-Chloro-N-cyclopropylpyrazin-2-amine (CAS 1209458-10-5)
- 2-[2-FLuoro-5-(tetramethyl-1,3,2-dioxaborolan-2-yl)phenyl]acetic acid (CAS 1431546-21-2)
- (Tyr?)-C-Peptide (dog) (CAS 101135-67-5)
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