Midazolam EP Impurity D CAS 59468-83-6
| CAS No. | 59468-83-6 |
| Molecular Formula | C18H13ClFN3O |
| Molecular Weight | 341.77 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 Midazolam EP Impurity D.
Midazolam EP Impurity D (CAS 59468-83-6) is a certified pharmaceutical impurity reference standard with the molecular formula C18H13ClFN3O and a molecular weight of 341.77 g/mol.
Structurally, Midazolam EP Impurity D (C18H13ClFN3O) contains a steroid core, an amide group, a hydroxyl group, an ether linkage, fluorine/chlorine substitution. The molecule exhibits a degree of unsaturation (DBE) of 13.0, corresponding to approximately 13 ring(s) or double-bond equivalent(s). With a molecular weight of 341.77 g/mol, it falls into the moderately-high-molecular-weight range. 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.
CATO manufactures Midazolam EP Impurity D under ISO 17034:2016 accreditation with dual CNAS and ANAB accreditation. Each batch is characterized by orthogonal methods and supplied with a full Certificate of Analysis (COA), ensuring metrological traceability.
Physical & Chemical Properties
| Molecular Formula | C18H13ClFN3O |
| Molecular Weight | 341.77 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) | 13.0 |
| 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 Impurity 1 (CAS 59468-90-5)
- Midazolam Impurity 41 (CAS 59468-85-8)
- Midazolam Impurity 32 (CAS CATO-C4X-150932)
- Midazolam Impurity 33 (CAS CATO-C4X-150933)
- Midazolam EP Impurity I (CAS 112811-67-3)
- Midazolam Impurity 25 (CAS CATO-C4X-150925)
- Midazolam Impurity 13 (CAS CATO-C4X-150913)
- Midazolam-d5 (Major) Discontinued See M343003 (CAS 395067-42-2)
Recommended Standards
- N'-[(1Z)-(2-Chloro-4-fluorophenyl)methylidene]-2-(1H-pyrrol-1-yl)benzohydrazide (CAS 478063-25-1)
- 5-Allyl-6-chloro-N-(2-fluoro-4-(methylsulfonyl)phenyl)pyrimidin-4-amine (CAS 1001397-14-3)
- N'-[(1E)-(2-Chloro-6-fluorophenyl)methylidene]-2-(1H-pyrrol-1-yl)benzohydrazide (CAS 347314-45-8)
- 4-(2-(2-(2-Chlorophenyl)-5-methyloxazol-4-yl)ethoxy)benzaldehyde (CAS 103789-58-8)
- Fluticasone Impurity 69 (CAS CATO-C4X-165069)
- Edaravone Impurity 23 (CAS 29214-62-8)
- Oxymetazoline impurity 9 (CAS CATO-C4X-17239)
- 2-Chloro-4-methyloxazole-5-carbonitrile (CAS 1823934-82-2)
- 3-{[(2-oxo-1,2,3,4-tetrahydroquinolin-6-yl)oxy]methyl}benzene-1-carboximidamide hydrochloride (CAS 1221726-19-7)
- Thiophen-2-ylmethyl carbamimidothioate hydrochloride (CAS 32415-42-2)
- Sulbactam EP Impurity G (CAS CATO-C4X-17567)
- 1'-Benzyl-[1,4'-bipiperidine]-2,2,3,3,4,4,5,5,6,6-d10-4'-carboxamide (CAS 1329616-19-4)
- 4-Pyrrolidinopyrindinyl(pentamethylcyclopentadienyl)iron (CAS 217458-65-6)
- C-Peptide 1 (rat) (CAS 41475-27-8)
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