Budesonide EP Impurity H (Mixture of Epimer) CAS 313474-58-7
| CAS No. | 313474-58-7 |
| Molecular Formula | C25H32O5 |
| Molecular Weight | 412.52 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
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.
As a process- or degradation-related impurity, Budesonide EP Impurity H (Mixture of Epimer) (CAS 313474-58-7, C25H32O5) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
Owing to a flavonoid core, a hydroxyl group, an ether linkage, Budesonide EP Impurity H (Mixture of Epimer) is typically pale yellow to yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 412.52 g/mol — guide the selection of appropriate sample preparation and analytical techniques. 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 | C25H32O5 |
| Molecular Weight | 412.52 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) | 10.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 2025 |
Related Budesonide Standards
- Budesonide Impurity 17 (CAS CATO-C4X-138917)
- Budesonide Impurity 60 (CAS CATO-C4X-138960)
- Budesonide 1,4,14-Triene Triol Impurity (CAS 131918-72-4)
- Budesonide Impurity N19 (CAS 3949-79-9)
- Budesonide Impurity 19 (Mixture of Epimer) (CAS 192057-49-1)
- Budesonide EP Impurity F(Desonide) (CAS 638-94-8)
- Budesonide Impurity 65 (CAS 2451560-12-4)
- Budesonide Impurity 50 (CAS 111668-12-3)
Recommended Standards
- Spironolactone Impurity 14 (CAS 53866-20-9)
- N-Nitroso Venlafaxine EP Impurity H (Mixture of Diastereomers) (CAS CATO-C4X-143453)
- Canagliflozin Impurity 58 (CAS CATO-C4X-112358)
- Dapoxetine Impurity 81 (CAS 2415108-74-4)
- Cefazolin Impurity 16 (CAS CATO-C4X-157716)
- Dopamine Impurity 112 (CAS CATO-C4X-1908112)
- Roxadustat Impurity 58 (CAS CATO-C4X-205858)
- 3-Azaspiro[5.5]undecane (CAS 180-44-9)
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- 2-(Trifluoromethyl)piperidine hydrochloride (CAS 627533-08-8)
- Ethyl 3-nitro-1H-pyrazole-4-carboxylate (CAS 66077-42-7)
- N-(4-(thiazol-2-yl)butyl)thietan-3-amine (CAS 1882601-98-0)
- 2-Cyano-n-(prop-2-en-1-yl)acetamide (CAS 30764-67-1)
- D-Val23-Tirzepatide (CAS CATO-CPTD788911)
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