Bendamustine Dihydroxy Impurity CAS 109882-29-3
| CAS No. | 109882-29-3 |
| Molecular Formula | C16H23N3O4 |
| Molecular Weight | N/A |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
As a process- or degradation-related impurity, Bendamustine Dihydroxy Impurity (CAS 109882-29-3, C16H23N3O4HCl) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
The molecular framework of Bendamustine Dihydroxy Impurity (C16H23N3O4HCl) is characterized by a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage, chlorine substitution. In reversed-phase chromatography, its retention is governed primarily by the protonation state of its nitrogen-containing groups, which provides a practical basis for HPLC-UV/DAD or LC-MS method development. 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 | C16H23N3O4 HCl |
| Molecular Weight | 357.83 g/mol |
| Appearance | Off-white to pale yellow crystalline powder. (slight halide-like odor) |
| Purity | 97%+ |
| Storage | Store at 2-8°C, protect from light, keep sealed and dry |
| Solubility (reference) | Soluble in DMSO, DMF, methanol |
| Stability | May oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light; Hygroscopic; reseal immediately after opening; Contains ester bond; hydrolyzes under strong alkaline conditions |
| Degree of Unsaturation (DBE) | 6.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 1988 |
| Halogen Content | Cl-containing |
| Nitrogen Atoms | 3 |
Related Bendamustine Standards
- Bendamustine impurity 33 (CAS 109882-25-9)
- Bendamustine Impurity 2 (CAS 109882-26-0)
- Bendamustine USP Related Compound E (CAS 109882-27-1)
- Bendamustine USP Related Compound A (CAS 109882-30-6)
- Bendamustine-D8 Hydrochloride (CAS 1134803-33-0)
- Bendamustine Impurity 7 (CAS 1138238-08-0)
- Bendamustine Dideschloroethyl Acid Hydrochloride (CAS 1179363-38-2)
- Bendamustine Impurity N20 (CAS 1219709-86-0)
Recommended Standards
- Moxifloxacin Impurity 53 (CAS 151213-45-5（free base）)
- Lorazepam Impurity 16 (CAS CATO-C4X-104116)
- Tolvaptan Impurity 89 (CAS 137977-65-2)
- 7-Bromo-[1,3]dioxolo[4,5-b]pyridine (CAS 1260663-83-9)
- Furan-3-yl(3-isopropoxyphenyl)methanol (CAS 1443325-36-7)
- 2-Chloro-3-methoxypyridine-4-carbaldehyde (CAS 905563-05-5)
- N-(3,5-Bis(trifluoromethyl)phenyl)-2-((4-ethyl-5-(pyrazin-2-yl)-4H-1,2,4-triazol-3-yl)thio)acetamide (CAS 587010-29-5)
- Acid-PEG25-NHS ester (CAS 2563872-17-1)
- Benzyl (2-((2-aminoethyl)(methyl)amino)cyclohexyl)carbamate (CAS 1353988-14-3)
- [3-31]-Semaglutide D (CAS C152H230N42O47)
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