Sitagliptin Phosphate Monohydrate EP Impurity B CAS 1345822-87-8
| CAS No. | 1345822-87-8 |
| Molecular Formula | C16H16F5N5O |
| 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 Sitagliptin Phosphate Monohydrate EP Impurity B.
As a process- or degradation-related impurity, Sitagliptin Phosphate Monohydrate EP Impurity B (CAS 1345822-87-8, C16H16F5N5OH3O4P) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
Sitagliptin Phosphate Monohydrate EP Impurity B (C16H16F5N5OH3O4P) contains a flavonoid core, an amide group, a phosphate ester group, a hydroxyl group, an ether linkage, fluorine 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. 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 Sitagliptin Phosphate Monohydrate EP Impurity B 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 | C16H16F5N5O H3O4P |
| Molecular Weight | 487.32 g/mol |
| Appearance | Off-white to pale yellow crystalline powder. (slight halide-like odor, low volatility) |
| Purity | 97%+ |
| Storage | Store in a cool place (≤25°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) | 7.5 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 1991 |
| Halogen Content | F-containing |
| Nitrogen Atoms | 5 |
Related Sitagliptin Standards
- Sitagliptin Impurity 17 (CAS 1036273-20-7)
- Sitagliptin Impurity 966 (CAS 1151240-88-8)
- Sitagliptin Impurity 14 (CAS 1151240-91-3)
- Sitagliptin Impurity 12 HCl (CAS 1151240-91-3（free base）)
- Sitagliptin Impurity 77 (CAS 1152439-73-0)
- Sitagliptin Impurity 97 (CAS 1169707-29-2)
- Sitagliptin Tablets EP Impurity FP-E HCl (CAS 1204818-19-8)
- Sitagliptin Impurity 15 (CAS 1217809-78-3)
Recommended Standards
- Baloxavir Marboxil Impurity 188 (CAS CATO-C4X-2108188)
- Atorvastatin Impurity 72 (CAS CATO-C4X-113272)
- Etrasimod Impurity 76 (CAS CATO-C4X-321476)
- (S)-2-Amino-2-(3-bromo-4-methoxyphenyl)ethan-1-ol (CAS 1213171-58-4)
- 2-(Methylsulfonyl)-1-(phenylsulfonyl)-1H-pyrrole (CAS 156210-91-2)
- Hydroxychloroquine Impurity 12 (CAS CATO-C4X-183512)
- 3-Ethoxy-5-iodo-4-((2-methylbenzyl)oxy)benzaldehyde (CAS 361369-08-6)
- 2-(6-Methoxy-2-pyridyl)acetic Acid (CAS 944896-97-3)
- Basmisanil (CAS 1159600-41-5)
- endo-Gly31-Semaglutide (CAS CATO-C4X-2226282)
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