Sitagliptin Impurity 136 HCl CAS 837430-22-5
| CAS No. | 837430-22-5 |
| 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 Impurity 136 HCl.
As a process- or degradation-related impurity, Sitagliptin Impurity 136 HCl (CAS 837430-22-5, C16H16F5N5OHCl) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
Sitagliptin Impurity 136 HCl (C16H16F5N5OHCl) contains a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage, fluorine/chlorine substitution. Halogen substitution raises its density and boiling point; these physicochemical properties determine the optimal preparation and storage of its standard solutions. The presence of an aromatic ring or conjugated system gives the compound characteristic absorption bands in the UV-Vis region, making it well suited to UV or diode-array detection (DAD).
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), Sitagliptin Impurity 136 HCl 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 | C16H16F5N5O HCl |
| Molecular Weight | 425.79 g/mol |
| Appearance | Pale yellow to yellow crystalline powder. (slight halide-like odor, low volatility) |
| Purity | >95% |
| Storage | Store at room temperature, protect from light |
| Solubility (reference) | Soluble in DMSO, DMF, methanol |
| Stability | May oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light |
| Degree of Unsaturation (DBE) | 8.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 1986 |
| Halogen Content | F/Cl-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
- Alogliptin Impurity 7 (CAS 1268836-55-0)
- Fluphenazine Decanoate EP Impurity F (CAS 13220-06-9)
- Phenylephrine Impurity 23 (CAS CATO-C4X-146723)
- Fmoc-HoCys(Mob)-OH (CAS 2044710-98-5)
- 1,3,3-Trimethyl-2-phenylpiperazine (CAS 802254-38-2)
- 3-(Azepan-2-yl)-5-(2-bromophenyl)-1,2,4-oxadiazole (CAS 1707563-51-6)
- Propranolol Impurity 40 (CAS CATO-C4X-151940)
- N-(4-aminobutyl)-5-chloro-2-methoxybenzamide hydrochloride (CAS 1840290-79-0)
- 6-Benzyl-2-oxo-1,6,8-triazatricyclo[7.4.0.0,3,7]trideca-3(7),4,8,10,12-pentaene-5-carboxylic acid (CAS 885461-22-3)
- Liraglutide-d8 Tetratrifluoroacetate (CAS 204656-20-2 (non-labelled, 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