Ivacaftor Impurity 11 CAS 13721-01-2
| CAS No. | 13721-01-2 |
| Molecular Formula | C10H7NO3 |
| Molecular Weight | 189.17 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 Ivacaftor Impurity 11.
CATO supplies Ivacaftor Impurity 11 (CAS 13721-01-2), a pharmacopoeial impurity reference standard (molecular formula C10H7NO3, MW 189.17 g/mol) used for the identification and quantification of trace impurities in APIs.
Structurally, Ivacaftor Impurity 11 (C10H7NO3) contains an amino-acid-derived structure, an amide group, a hydroxyl group, an ether linkage. 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 189.17 g/mol, it falls into the medium-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.
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 | C10H7NO3 |
| Molecular Weight | 189.17 g/mol |
| Appearance | Pale yellow to yellow crystalline powder. (faint amine-like odor) |
| Purity | >95% |
| Storage | Store at 2-8°C, protect from light, keep sealed and dry |
| Solubility (reference) | Soluble in methanol, ethanol, DMSO |
| Stability | May oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light; Hygroscopic; reseal immediately after opening |
| Degree of Unsaturation (DBE) | 8.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 1960 |
| Nitrogen Atoms | 1 |
Related Ivacaftor Standards
- Ivacaftor Impurity 12 (CAS CATO-C4X-296412)
- Ivacaftor Impurity 7 (CAS 52980-28-6)
- Ivacaftor Impurity 9 (CAS 26892-90-0)
- Ivacaftor impurity 17 (CAS CATO-C4X-296417)
- Ivacaftor Impurity 10 (CAS 873055-58-4)
- Ivacaftor Impurity 13 (CAS 529-37-3)
- Ivacaftor Impurity 3 (CAS 873055-57-3)
- Ivacaftor Impurity 14 (CAS 54535-22-7)
Recommended Standards
- Vericiguat Impurity 102 (CAS 15106-70-4)
- Methyl aminolevulinate Impurity 12 (CAS CATO-C4X-299312)
- Cycloserine Impurity 11 (CAS CATO-C4X-226411)
- Metronidazole-hydroxy D2 (CAS 2196180-19-3)
- Roxatidine Impurity 35 Hydrochloride (CAS CATO-C4X-121335)
- Budesonide Impurity 79 (Z-Isomer) (CAS 118866-09-4)
- Acetazolamide EP Impurity C (CAS 32873-56-6)
- Ethyl 3-(1-Tetrazolyl)benzoate (CAS 168618-33-5)
- Ethyl 5,5-difluoro-1-methyl-4,5,6,7-tetrahydro-1H-indazole-3-carboxylate (CAS 2114517-14-3)
- 2-(Difluoromethyl)-6-iodopyridine-3-carbonyl chloride (CAS 1805121-23-6)
- 3-Fluoro-2-(trifluoromethyl)benzamide (CAS 287398-80-5)
- 2,3-Dichloro-5-(difluoromethoxy)benzaldehyde (CAS 1803787-03-2)
- 1-Methoxybut-3-en-2-one (CAS 43042-58-6)
- Peptide Impurity 04 (CAS 2913424-91-4)
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