Sitagliptin Impurity 58 CAS 667-35-6
| CAS No. | 667-35-6 |
| Molecular Formula | C4H2F6N2O2 |
| Molecular Weight | 224.06 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
CATO manufactures Sitagliptin Impurity 58 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.
CATO supplies Sitagliptin Impurity 58 (CAS 667-35-6), a pharmacopoeial impurity reference standard (molecular formula C4H2F6N2O2, MW 224.06 g/mol) used for the identification and quantification of trace impurities in APIs.
The molecular framework of Sitagliptin Impurity 58 (C4H2F6N2O2) is characterized by an amide group, a carboxylic acid group, a hydroxyl group, an ether linkage, fluorine substitution. 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. 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.
Physical & Chemical Properties
| Molecular Formula | C4H2F6N2O2 |
| Molecular Weight | 224.06 g/mol |
| Purity | >95% |
| Storage | Store at 2-8°C, protect from light, keep sealed and dry, keep tightly closed to prevent evaporation |
| Solubility (reference) | Soluble in DMSO, DMF, methanol |
| Stability | Light-sensitive; avoid direct strong light; Hygroscopic; reseal immediately after opening; Contains ester bond; hydrolyzes under strong alkaline conditions |
| Degree of Unsaturation (DBE) | 2.0 |
| CAS Registry Year (est.) | 1957 |
| Halogen Content | F-containing |
| Nitrogen Atoms | 2 |
Related Sitagliptin Standards
- Sitagliptin Impurity 78-d4 (CAS 2892260-32-9 (unlabelled))
- Sitagliptin Impurity 78 (Nitroso-STG-19) (NTTP) (CAS 2892260-32-9)
- Sitagliptin Impurity 118 (CAS 1261633-32-2)
- Sitagliptin Impurity 147 (CAS 1481965-39-2)
- Sitagliptin Impurity 127 (CAS CATO-C4X-1144127)
- Sitagliptin Impurity 59 (CAS CATO-C4X-114459)
- Sitagliptin Impurity 166 (CAS 2226094-64-8)
- Sitagliptin Impurity 167 (CAS 1840966-95-1)
Recommended Standards
- 918811-38-8 6-Bromophthalazin-1-amine DTXSID70733171 (CAS 918811-38-8)
- Brimonidine EP Impurity B (CAS 50358-63-9)
- 7-Bromoquinoxalin-2-amine (CAS 212327-11-2)
- Brimonidine Impurity 21 (CAS 1378255-24-3)
- Bilastine Impurity 73 (CAS 874895-87-1)
- Travoprost Impurity 51 (CAS CATO-C4X-192551)
- Regadenoson Impurity 21 (CAS 146-77-0)
- (E)-morpholine-4-carbohydrazonamide hydroiodide (CAS 24777-76-2)
- 3-(3-Hydroxy-4-methoxyphenyl)-1-(2,4,6-trihydroxyphenyl)propan-1-one (CAS 35400-60-3)
- 1-Benzyloxycarbonyl-4-tert-butoxycarbonyl-1,4-diazepane-6-carboxylicacid (CAS 2200388-70-9)
- 2-iodo-4-(methylsulfanyl)benzonitrile (CAS 54558-83-7)
- 4-Bromo-3-iodo-1H-indazol-6-ol (CAS 887568-93-6)
- 5,6-Difluoro-7-methyl-1H-indole (CAS 1820607-52-0)
- Exenatide (CAS 141758-74-9（free base）)
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