Ketoconazole Impurity 35 CAS CATO-C4X-147235
| CAS No. | CATO-C4X-147235 |
| Molecular Formula | C14H14Cl2N2O3 |
| Molecular Weight | 329.18 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 Ketoconazole Impurity 35.
CATO supplies Ketoconazole Impurity 35 (CAS CATO-C4X-147235), a pharmacopoeial impurity reference standard (molecular formula C14H14Cl2N2O3, MW 329.18 g/mol) used for the identification and quantification of trace impurities in APIs.
Structurally, Ketoconazole Impurity 35 (C14H14Cl2N2O3) contains a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage, chlorine substitution. The molecule exhibits a degree of unsaturation (DBE) of 8.0, corresponding to approximately 8 ring(s) or double-bond equivalent(s). With a molecular weight of 329.18 g/mol, it falls into the moderately-high-molecular-weight range. Nitrogen-containing functional groups confer excellent ionization efficiency in positive-ion electrospray (ESI) mode, making the compound well suited to LC-MS/MS analysis.
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 Ketoconazole Impurity 35 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 | C14H14Cl2N2O3 |
| Molecular Weight | 329.18 g/mol |
| Appearance | Pale yellow to yellow crystalline powder. (slight halide-like odor, low volatility) |
| 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) | 8.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| Halogen Content | Cl-containing |
| Nitrogen Atoms | 2 |
Related Ketoconazole Standards
- Ketoconazole Impurity 10 (CAS 61441-65-4)
- Ketoconazole Impurity 11 (CAS 84682-23-5)
- Ketoconazole Impurity 13 (and enantiomer) (CAS 61397-58-8)
- Ketoconazole Impurity 14 (CAS 170210-49-8)
- Ketoconazole Impurity N15 (CAS 170210-42-1)
- Ketoconazole Impurity 20 (CAS CATO-C4X-147220)
- Ketoconazole Impurity 19 (CAS CATO-C4X-147219)
- Ketoconazole impurity 31 (CAS CATO-C4X-147231)
Recommended Standards
- Prothiophos-Oxon (CAS 38527-91-2)
- 5-Bromo-2-fluoro-N-((4-methylthiazol-2-yl)methyl)benzamide (CAS 1007737-10-1)
- Tadalafil Impurity 58 (CAS CATO-C4X-108758)
- 4-[5-Bromo-4-(morpholin-4-yl)pyrimidin-2-yl]morpholine (CAS 1021268-12-1)
- Eravacycline impurity 37 (CAS CATO-C4X-293837)
- Alvimopan Impurity N12 (CAS 59381-63-4)
- Posaconazole Impurity 75 (CAS CATO-C4X-120875)
- B-[4-(10-Phenyl-9-anthracenyl)-1-naphthalenyl]boronic acid (CAS 1404067-48-6)
- 2-Ethoxy-4-methyl-5-(4,4,5,5-tetramethyl-1,3,2-dioxaborolan-2-yl)pyridine (CAS 1309982-67-9)
- (2S,3’S)-N-[3-t-Butoxycarbonyl-3-benzyloxycarbonylamino-propyl]]azetidine-2-carboxylic Acid, t-Butyl Ester (CAS 1235453-07-2)
- N-((4,5-Dihydro-1H-imidazol-2-yl)methyl)-3-fluoro-2-methylaniline (CAS 792153-97-0)
- exo-3-Amino-8-Boc-8-azabicyclo[3.2.1]octane acetate (CAS 2007910-58-7)
- 4-Fluoro-N-(2-furylmethyl)-1,3-benzothiazol-2-amine (CAS 1350989-02-4)
- Peptide Impurity 26 (CAS 1350456-66-4)
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