Osimertinib Impurity 37 TFA salt CAS CATO-C4X-2045103
| CAS No. | CATO-C4X-2045103 |
| Molecular Formula | C27H30N8O3 |
| Molecular Weight | N/A |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
CATO supplies Osimertinib Impurity 37 TFA salt (CAS CATO-C4X-2045103), a pharmacopoeial impurity reference standard (molecular formula C27H30N8O3C2HF3O2, MW 628.61 g/mol) used for the identification and quantification of trace impurities in APIs.
Structurally, Osimertinib Impurity 37 TFA salt (C27H30N8O3C2HF3O2) contains a steroid core, an amide group, a hydroxyl group, an ether linkage, fluorine substitution. The molecule exhibits a degree of unsaturation (DBE) of 17.0, corresponding to approximately 17 ring(s) or double-bond equivalent(s). With a molecular weight of 628.61 g/mol, it falls into the high-molecular-weight range. 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.
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 | C27H30N8O3 C2HF3O2 |
| Molecular Weight | 628.61 g/mol |
| 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) | 17.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| Halogen Content | F-containing |
| Nitrogen Atoms | 8 |
Related Osimertinib Standards
- Osimertinib Impurity 5 (CAS 1009298-59-2)
- Osimertinib Impurity 8 (CAS 1421372-66-8)
- Osimertinib Impurity N1 (CAS 1421372-67-9)
- Osimertinib Impurity N2 (CAS 1421373-36-5 (free base))
- Osimertinib (CAS 1421373-65-0)
- Osimertinib Impurity 10 (CAS 1421373-98-9)
- Osimertinib Impurity N3 (CAS 1421373-99-0)
- Osimertinib-3 (CAS 1446700-26-0)
Recommended Standards
- Clindamycin Impurity 95 (CAS CATO-C4X-134195)
- Ropivacaine Impurity 15 (CAS CATO-C4X-175315)
- Paliperidone Impurity 107 HCl (CAS CATO-C4X-1724107)
- 4,4,5,5-Tetramethyl-2-(5-methyl-1-cyclohexen-1-yl)-1,3,2-dioxaborolane (CAS 1046831-99-5)
- Vinaginsenoside R3 (CAS 156012-92-9)
- N-(benzo[d][1,3]dioxol-4-ylmethyl)hexan-1-amine (CAS 1154338-39-2)
- Cefoxitin Impurity 23 (CAS CATO-C4X-157823)
- 2-(6-Amino-1h-indol-1-yl)acetic acid (CAS 1248180-84-8)
- 2-azidonaphthalene (CAS 20937-86-4)
- 30003-72-6 insulin chain b oxidized (CAS 30003-72-6)
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