Insulin Degludec Impurity 9 CAS CATO-C4X-21579
| CAS No. | CATO-C4X-21579 |
| Molecular Formula | C29H53NO7 |
| Molecular Weight | 527.73 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 Insulin Degludec Impurity 9.
Insulin Degludec Impurity 9 (CAS CATO-C4X-21579) is a certified pharmaceutical impurity reference standard with the molecular formula C29H53NO7 and a molecular weight of 527.73 g/mol.
The molecular framework of Insulin Degludec Impurity 9 (C29H53NO7) is characterized by a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage. In reversed-phase chromatography, its retention is governed primarily by the protonation state of its nitrogen-containing groups, which provides a practical basis for HPLC-UV/DAD or LC-MS method development. 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.
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 | C29H53NO7 |
| Molecular Weight | 527.73 g/mol |
| Appearance | Off-white to pale yellow crystalline powder |
| Purity | 97%+ |
| Storage | Store at room temperature, protect from light, keep sealed and dry |
| Solubility (reference) | Soluble in methanol, acetonitrile, DMSO, water (slightly soluble) |
| Stability | May oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light |
| Degree of Unsaturation (DBE) | 4.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| Nitrogen Atoms | 1 |
Related Insulin Standards
- Insulin Degludec Impurity 25 (CAS CATO-C4X-215725)
- Insulin Degludec Impurity 28 (CAS CATO-C4X-215728)
- Insulin B (22-25) (CAS 34367-73-2)
- Insulin Degludec Impurity 16 (CAS CATO-C4X-215716)
- Insulin Degludec Impurity 10 (CAS CATO-C4X-215710)
- Insulin Degludec Impurity 14 (CAS CATO-C4X-215714)
- Insulin Degludec Impurity 15 (CAS CATO-C4X-215715)
- Insulin Degludec Impurity 19 (CAS CATO-C4X-215719)
Recommended Standards
- 5-(2-(1-Ethylnaphtho[1,2-d]thiazol-2(1H)-ylidene)ethylidene)-3-heptyl-1-phenyl-2-thioxoimidazolidin-4-one (CAS 15664-19-4)
- (S)-2-((S)-3-(1H-Indol-3-yl)-2-tetradecanamidopropanamido)-4-methylpentanoic acid (CAS 192722-67-1)
- (1R,2S,5S)-3-((S)-2-(3-(1-(tert-butylsulfonylmethyl)cyclohexyl)ureido)-3,3-dimethylbutanoyl)-6,6-dimethyl-3-azabicyclo[3.1.0]hexane-2-carboxylic acid (CAS 1229337-32-9)
- (E)-2,6-Dimethyl-N-(1-(9-(2,4,6-triisopropylphenyl)-1,10-phenanthrolin-2-yl)ethylidene)aniline (CAS 2751681-01-1)
- Cilnidipine Impurity 6 (CAS 146845-34-3)
- Terazosin EP Impurity H HCl (CAS 105356-90-9 (free base))
- Argatroban Impurity 24 (CAS 74874-10-5)
- 159276-58-1 1-(3-Bromoprop-1-en-2-yl)-2,4-difluorobenzene DTXSID00473174 (CAS 159276-58-1)
- 8-Ethyl-7h-purine (CAS 6625-65-6)
- 2-Cyclopropyl-4H,5H,6H,7H-pyrazolo[1,5-a]pyrazine hydrochloride (CAS 2126176-89-2)
- 1-Benzyl-4-(3-phenyl-1,2,4-oxadiazol-5-yl)pyrrolidin-2-one (CAS 1172783-48-0)
- tert-Butyl (2-((S)-2-amino-N-cyclopropylpropanamido)cyclohexyl)carbamate (CAS 1354025-32-3)
- 3-Methyl-4-oxo-4-phenylbutanoic acid (CAS 7315-67-5)
- Semaglutide impurity 72 (CAS CATO-C4X-222672)
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