Biotin EP Impurity D(Mixture of Diastereomers) CAS 415725-35-8
| CAS No. | 415725-35-8 |
| Molecular Formula | C11H18N2O3S |
| Molecular Weight | 258.34 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
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.
Biotin EP Impurity D(Mixture of Diastereomers) (CAS 415725-35-8) is a certified pharmaceutical impurity reference standard with the molecular formula C11H18N2O3S and a molecular weight of 258.34 g/mol.
Based on its molecular formula C11H18N2O3S, Biotin EP Impurity D(Mixture of Diastereomers) contains a nitrogen-containing heterocyclic scaffold, an amide group, a sulfone group, a hydroxyl group, an ether linkage; these features give the compound characteristic absorption bands in UV spectroscopy. The molecular weight of 258.34 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).
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.
Physical & Chemical Properties
| Molecular Formula | C11H18N2O3S |
| Molecular Weight | 258.34 g/mol |
| Purity | 97%+ |
| Storage | Store at 2-8°C, protect from light, keep sealed and dry |
| Solubility (reference) | Soluble in methanol, ethanol, DMSO |
| Stability | May oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light; Hygroscopic; reseal immediately after opening |
| Degree of Unsaturation (DBE) | 4.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 2025 |
| Nitrogen Atoms | 2 |
| Sulfur Atoms | 1 |
Related Biotin Standards
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- Tegoprazan Impurity 125 (CAS CATO-C4X-2297125)
- 2-Aminooxazolo[4,5-b]pyridine (CAS 40926-66-7)
- 2-Methoxy-3-(trifluoromethyl)pyridine-4-acetonitrile (CAS 1227594-86-6)
- Methyl 3-chloro-6-iodopicolinate (CAS 1245735-42-5)
- 3-Formyl-4-methylbenzonitrile (CAS 27613-39-4)
- Methyl 3-hydroxyazetidine-3-carboxylate (CAS 950691-64-2)
- 2-Bromo-6-(trifluoromethyl)quinoxaline (CAS 1240595-08-7)
- Semaglutide impurity 214 (CAS CATO-C4X-2226214)
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