Midazolam Impurity 16 CAS 59467-64-0
| CAS No. | 59467-64-0 |
| Molecular Formula | C16H15ClFN3 |
| Molecular Weight | 303.76 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
CATO supplies Midazolam Impurity 16 (CAS 59467-64-0), a pharmacopoeial impurity reference standard (molecular formula C16H15ClFN3, MW 303.76 g/mol) used for the identification and quantification of trace impurities in APIs.
Structurally, Midazolam Impurity 16 (C16H15ClFN3) contains a nitrogen-containing heterocyclic scaffold, a nitrile group, fluorine/chlorine substitution. The molecule exhibits a degree of unsaturation (DBE) of 10.0, corresponding to approximately 10 ring(s) or double-bond equivalent(s). With a molecular weight of 303.76 g/mol, it falls into the moderately-high-molecular-weight range. The high carbon-to-hydrogen ratio imparts good lipophilicity, allowing liquid-liquid extraction with non-polar solvents such as n-hexane or ethyl acetate.
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 | C16H15ClFN3 |
| Molecular Weight | 303.76 g/mol |
| Appearance | Pale yellow to 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) | 10.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 1973 |
| Halogen Content | F/Cl-containing |
| Nitrogen Atoms | 3 |
Related Midazolam Standards
- Midazolam N-Methyl Impurity (CAS 59467-61-7)
- Midazolam EP Impurity G (CAS 59467-86-6)
- Midazolam Impurity 43 (CAS CATO-C4X-150943)
- Midazolam Impurity 23 (CAS CATO-C4X-150923)
- Midazolam EP Impurity F (CAS 2886-65-9)
- 【禁售不询】Midazolam (CAS 59467-70-8)
- Midazolam EP Impurity B (CAS 59469-74-8)
- Midazolam Impurity 28 (CAS CATO-C4X-150928)
Recommended Standards
- 898772-03-7 {3-[(Azetidin-1-yl)methyl]phenyl}(4-chloro-2-fluorophenyl)methanone DTXSID40643273 (CAS 898772-03-7)
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- 898756-92-8 {4-[(Azetidin-1-yl)methyl]phenyl}(4-chloro-2-fluorophenyl)methanone DTXSID20642820 (CAS 898756-92-8)
- 1-(4-(3-Chlorothiophen-2-yl)-6-methylpyrimidin-2-yl)-1H-pyrrole-2-carbaldehyde (CAS 860788-76-7)
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- 2,5-Bis(dimethylamino)cyclohexa-2,5-diene-1,4-dione (CAS 1521-02-4)
- FCCP (CAS 370-86-5)
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Why CATO?
- ISO 17034 accredited reference material producer (CNAS + ANAB dual accreditation)
- 130,000+ catalog items in stock, COA supplied with every batch
- Worldwide shipping with full export documentation (HS code guidance available)
- Technical support: +86 18665070610 / Nicole.chen@cato-chem.com