Bromhexine EP Impurity D(2HCl) CAS 10076-98-9
| CAS No. | 10076-98-9 |
| Molecular Formula | C14H21BrN2 |
| Molecular Weight | N/A |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
As a certified reference material (CRM), Bromhexine EP Impurity D(2HCl) meets the metrological traceability requirements of ISO/IEC 17025 laboratories. Batch-to-batch consistency is monitored via control charts to guarantee comparable assigned values across lots.
As a process- or degradation-related impurity, Bromhexine EP Impurity D(2HCl) (CAS 10076-98-9, C14H21BrN2HCl) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
Owing to a nitrogen-containing heterocyclic scaffold, a nitrile group, chlorine/bromine substitution, Bromhexine EP Impurity D(2HCl) is typically off-white to pale yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 333.70 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).
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 | C14H21BrN2 2*HCl |
| Molecular Weight | 333.70 g/mol |
| Appearance | Off-white to pale yellow crystalline powder. (slight halide-like odor, low volatility) |
| Purity | >95% |
| Storage | Store at 2-8°C, protect from light |
| Solubility (reference) | Soluble in DMSO, DMF, methanol |
| Stability | May oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light |
| Degree of Unsaturation (DBE) | 4.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 1959 |
| Halogen Content | Cl/Br-containing |
| Nitrogen Atoms | 2 |
Related Bromhexine Standards
- Bromhexine Impurity 35 (CAS 100-60-7)
- Bromhexine impurity 59 (CAS 100669-81-6)
- Bromhexine Impurity 51 (CAS 100669-82-7)
- Bromhexine Impurity 22 (CAS 114059-99-3)
- Bromhexine Impurity 17 (CAS 114390-40-8)
- Bromhexine Impurity N3 (CAS 114390-41-9)
- Bromhexine impurity 60 (CAS 1261676-18-9)
- Bromhexine impurity 57 (CAS 1261684-10-9)
Recommended Standards
- Lysine Impurity 9 (CAS CATO-C4X-22119)
- Ferulic Acid Impurity 7 (CAS CATO-C4X-22727)
- Bumetanide Impurity 114 (CAS CATO-C4X-1986114)
- 4-Bromo-3-fluoro-5-sulfamoylbenzoic acid (CAS 1339379-03-1)
- Oxybuprocaine EP Impurity B (CAS 23442-22-0)
- 1-(1H-Indol-1-yl)propan-1-one (CAS 73747-53-2)
- Tepotinib impurity 6 (CAS CATO-C4X-33746)
- 3-(3-Chlorophenyl)-2-methylprop-2-enoic acid (CAS 109619-78-5)
- 2,4-Dichloro-alpha-methyl-benzeneacetic acid, methyl ester (CAS 66246-55-7)
- D-Ser32-Tirzepatide (CAS CATO-CPTD788677)
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