Fenofibrate Impurity 19 CAS CATO-C4X-164319
| CAS No. | CATO-C4X-164319 |
| Molecular Formula | C9H22NO3 |
| Molecular Weight | N/A |
| 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 Fenofibrate Impurity 19.
CATO supplies Fenofibrate Impurity 19 (CAS CATO-C4X-164319), a pharmacopoeial impurity reference standard (molecular formula C9H22NO3I, MW 319.18 g/mol) used for the identification and quantification of trace impurities in APIs.
Fenofibrate Impurity 19 (C9H22NO3I) contains an amide group, a carboxylic acid group, a hydroxyl group, an ether linkage, iodine substitution. It is notably hygroscopic, halogen substitution raises its density and boiling point, the carboxyl group imparts weak acidity; these physicochemical properties determine the optimal preparation and storage of its standard solutions. Halogen substitution (F/Cl/Br/I) produces a distinctive isotope pattern in mass spectrometry, a valuable aid for qualitative confirmation.
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.
As a certified reference material (CRM), Fenofibrate Impurity 19 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.
Physical & Chemical Properties
| Molecular Formula | C9H22NO3 I |
| Molecular Weight | 319.18 g/mol |
| Purity | ≥95% |
| Storage | Store at 2-8°C, protect from light, keep sealed and dry |
| Solubility (reference) | Soluble in methanol, ethanol, DMSO |
| Stability | Light-sensitive; avoid direct strong light; Hygroscopic; reseal immediately after opening; Contains ester bond; hydrolyzes under strong alkaline conditions |
| Degree of Unsaturation (DBE) | -1.0 |
| Halogen Content | I-containing |
| Nitrogen Atoms | 1 |
Related Fenofibrate Standards
- Fenofibrate Impurity 19 (CAS 10547-60-1)
- Fenofibrate EP Impurity B-d6 (Fenofibric Acid-d6) (CAS 1092484-69-9)
- Fenofibrate EP Impurity F (CAS 154356-96-4)
- Fenofibrate Impurity N3 (CAS 1871-38-1)
- Fenofibrate EP Impurity C (CAS 217636-47-0)
- Fenofibrate EP Impurity G (CAS 217636-48-1)
- Fenofibrate Impurity 34 (CAS 258834-37-6)
- Fenofibrate Impurity 15 (CAS 34183-01-2)
Recommended Standards
- Clindamycin Impurity 4 (CAS CATO-C4X-13414)
- Amlodipine Impurity 25 (CAS 3891-07-4)
- Cefazolin Impurity 89 (CAS CATO-C4X-157789)
- 2-(3,5-Dichlorophenyl)-2-(3-methylpiperidin-1-yl)ethanamine (CAS 1216139-45-5)
- 2H-Pyran-4-amine, N-(5-bromo-2-nitrophenyl)tetrahydro- (CAS 1162696-22-1)
- 5-Guanidinonicotinic acid (CAS 735253-08-4)
- 1-(Dimethylcarbamoyl)piperidine-3-carboxylic Acid (CAS 702670-21-1)
- Phycocyanobilin (CAS 20298-86-6)
- N-(4-Chlorophenyl)ethenesulfonamide (CAS 89978-95-0)
- Semaglutide impurity 276 (CAS CATO-C4X-2226276)
Why CATO?
- ISO 17034 accredited reference material producer (CNAS + ANAB dual accreditation)
- 130,000+ catalog items in stock, COA supplied with every batch
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- Technical support: +86 18665070610 / Nicole.chen@cato-chem.com