Bisoprolol Impurity 48 CAS 1416440-64-6
| CAS No. | 1416440-64-6 |
| Molecular Formula | C15H22O5 |
| Molecular Weight | 282.33 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 Bisoprolol Impurity 48.
As a process- or degradation-related impurity, Bisoprolol Impurity 48 (CAS 1416440-64-6, C15H22O5) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
Bisoprolol Impurity 48 (C15H22O5) contains a carboxylic acid group, a hydroxyl group, an ether linkage, an aromatic ring system. The carboxyl group imparts weak acidity; these physicochemical properties determine the optimal preparation and storage of its standard solutions. 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 | C15H22O5 |
| Molecular Weight | 282.33 g/mol |
| Appearance | Off-white to pale yellow crystalline powder |
| Purity | 97%+ |
| Storage | Store at room temperature, keep sealed and dry |
| Solubility (reference) | Soluble in methanol, acetonitrile, DMSO, water (slightly soluble) |
| Stability | May oxidize slowly on prolonged air exposure |
| Degree of Unsaturation (DBE) | 5.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 1991 |
Related Bisoprolol Standards
- Bisoprolol Impurity 85 (CAS CATO-C4X-124785)
- Bisoprolol Impurity 73 (CAS CATO-C4X-124773)
- Bisoprolol Impurity 29 (CAS 1797024-50-0)
- Bisoprolol Impurity 80 (CAS 188128-73-6)
- Bisoprolol Impurity 64 (CAS CATO-C4X-124764)
- Bisoprolol Impurity 108 (CAS 2615193-96-7)
- Bisoprolol Impurity 107 (CAS CATO-C4X-1247107)
- Bisoprolol Hydroxyethyl Ester Impurity (CAS 1346601-19-1)
Recommended Standards
- 898764-15-3 Ethyl 4-(3-phenylpropanoyl)benzoate DTXSID60643972 (CAS 898764-15-3)
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- 861439-58-9 3-[(2-Allylphenoxy)methyl]-4-methoxybenzaldehyde MFCD03030302 (CAS 861439-58-9)
- Propafenone Hydrochloride EP Impurity C (CAS CATO-C4X-132238)
- Rosuvastatin Impurity 265 (CAS CATO-C4X-1169265)
- Mirogabalin Impurity (CAS 1138245-20-1)
- Difelikefalin Impurity 76 (CAS CATO-C4X-304176)
- 4,4,5,5-Tetramethyl-2-(4-phenylfuran-2-yl)-1,3,2-dioxaborolane (CAS 1242517-60-7)
- N-(5-amino-2-methylphenyl)propane-1-sulfonamide hydrochloride (CAS 1795188-51-0)
- N-(2-Fluorobenzyl)-2,5-dimethylaniline (CAS 1020961-62-9)
- 2-((2,2-Dimethyl-2,3-dihydrobenzofuran-7-yl)oxy)ethanamine hydrochloride (CAS 680203-71-8)
- Fasudil Impurity 25 (CAS CATO-C4X-136525)
- (S)-((4-bromophenyl)(hydroxy)methyl)phosphonic acid (CAS 1462329-72-1)
- Q-Peptide trifluoroacetate salt (CAS 1361235-89-3)
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