Osimertinib Impurity 91 CAS CATO-C4X-204591
| CAS No. | CATO-C4X-204591 |
| Molecular Formula | C38H43N9O4 |
| Molecular Weight | 689.81 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
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.
As a process- or degradation-related impurity, Osimertinib Impurity 91 (CAS CATO-C4X-204591, C38H43N9O4) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
Osimertinib Impurity 91 (C38H43N9O4) contains a nitrogen-containing heterocyclic scaffold, 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. 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.
Physical & Chemical Properties
| Molecular Formula | C38H43N9O4 |
| Molecular Weight | 689.81 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 |
| Degree of Unsaturation (DBE) | 22.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| Nitrogen Atoms | 9 |
Related Osimertinib Standards
- Osimertinib Impurity 93 (CAS CATO-C4X-204593)
- Osimertinib Impurity 86 (CAS CATO-C4X-204586)
- Osimertinib Impurity 79 (CAS CATO-C4X-204579)
- Osimertinib Impurity 85 (CAS CATO-C4X-204585)
- Osimertinib Impurity 71 (CAS CATO-C4X-204571)
- Osimertinib Impurity 4 (AZD2015) (CAS CATO-C4X-20455)
- Osimertinib impurity 59 (CAS CATO-C4X-204559)
- Osimertinib Impurity 97 (CAS CATO-C4X-204597)
Recommended Standards
- (11bS)-N-allyl-N-benzhydryl-2,6-diphenyldinaphtho[2,1-d:1',2'-f][1,3,2]dioxaphosphepin-4-amine (CAS 2375836-78-3)
- Phosphazene base P₄-t-Oct solution (CAS 153136-05-1)
- Cefditoren Impurity 59 (CAS CATO-C4X-135859)
- (S,R,S)-AHPC-PEG4-N3 (CAS 1797406-81-5)
- Ramosetron Impurity 7 (CAS CATO-C4X-11827)
- Clonazepam impurity 7 (CAS CATO-C4X-14037)
- Torasemide impurity 37 (CAS CATO-C4X-183637)
- 4-(Nonan-2-ylamino)butan-2-ol (CAS 1340419-35-3)
- ethyl 4-(1-methyl-1h-pyraZol-4-yl)-2,4-dioxobutanoate (CAS 873221-73-9)
- N-(furan-2-ylmethyl)-3-(pyrrolidin-1-yl)propan-1-amine (CAS 1042589-83-2)
- 3-Isopropylisothiazole-4-carbonitrile (CAS 1496495-94-3)
- 3-(3-Chloropropanoyl)-1-(2,2,2-trifluoroethyl)urea (CAS 1094363-47-9)
- (S)-2-((tert-Butoxycarbonyl)amino)-5-(pyrazine-2-carboxamido)pentanoic acid (CAS 201046-36-8)
- Insulin Degludec Impurity 26 (CAS CATO-C4X-215726)
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