Tadalafil EP Impurity A CAS 171596-27-3
| CAS No. | 171596-27-3 |
| Molecular Formula | C22H19N3O4 |
| Molecular Weight | 389.40 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
CATO supplies Tadalafil EP Impurity A (CAS 171596-27-3), a pharmacopoeial impurity reference standard (molecular formula C22H19N3O4, MW 389.40 g/mol) used for the identification and quantification of trace impurities in APIs.
Tadalafil EP Impurity A (C22H19N3O4) contains a flavonoid core, an amide group, a hydroxyl group, an ether linkage. It is notably hygroscopic, 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.
As a certified reference material (CRM), Tadalafil EP Impurity A 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 | C22H19N3O4 |
| Molecular Weight | 389.40 g/mol |
| Appearance | Pale yellow to yellow crystalline powder |
| Purity | >90% |
| Storage | Store at 2-8°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 |
| Degree of Unsaturation (DBE) | 15.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 2006 |
| Nitrogen Atoms | 3 |
Related Tadalafil Standards
- Tadalafil (CAS 171596-29-5)
- Tadalafil EP Impurity B (CAS 629652-72-8)
- Tadalafil Impurity 25 (CAS CATO-C4X-108725)
- Tadalafil EP Impurity C (CAS 171596-28-4)
- Tadalafil Impurity 75 (CAS 1093940-68-1)
- Tadalafil Impurity 76 (CAS 1093940-70-5)
- Tadalafil Impurity 72 (CAS 20696-60-0)
- Tadalafil impurity 165 (CAS 385769-80-2)
Recommended Standards
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- Rivaroxaban impurity 195 (CAS CATO-C4X-1090195)
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- Des-Ile12-Aib13-Tirzepatide (CAS CATO-CPTD788960)
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