Gemcitabine Impurity 11 CAS 134790-39-9
| CAS No. | 134790-39-9 |
| Molecular Formula | C23H19F2N3O6 |
| Molecular Weight | 471.41 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
Gemcitabine Impurity 11 (CAS 134790-39-9) is a certified pharmaceutical impurity reference standard with the molecular formula C23H19F2N3O6 and a molecular weight of 471.41 g/mol.
Based on its molecular formula C23H19F2N3O6, Gemcitabine Impurity 11 contains a flavonoid core, an amide group, a hydroxyl group, an ether linkage, fluorine substitution; these features give the compound characteristic absorption bands in UV spectroscopy. The molecular weight of 471.41 g/mol is directly relevant to the identification of the molecular ion in mass spectrometry. The aromatic system may exhibit native fluorescence, enabling detection with a fluorescence detector (FLD).
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 | C23H19F2N3O6 |
| Molecular Weight | 471.41 g/mol |
| Appearance | Pale yellow to yellow crystalline powder. (slight halide-like odor, low volatility) |
| Purity | >95% |
| 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) | 15.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 1995 |
| Halogen Content | F-containing |
| Nitrogen Atoms | 3 |
Related Gemcitabine Standards
- Gemcitabine Impurity 16 (CAS CATO-C4X-137216)
- Gemcitabine Impurity 27 (CAS 1268237-46-2)
- Gemcitabine Impurity 28 (CAS 134790-40-2)
- Gemcitabine Impurity 38 (CAS CATO-C4X-137238)
- Gemcitabine Impurity 30 (CAS 143157-27-1)
- Gemcitabine Impurity 34 (CAS CATO-C4X-137234)
- Gemcitabine Impurity 35 (CAS CATO-C4X-137235)
- Gemcitabine Impurity 10 (CAS 122111-11-9)
Recommended Standards
- N-(2-bromophenyl)-2-((5-cyclohexyl-4-phenyl-4H-1,2,4-triazol-3-yl)thio)acetamide (CAS 332872-86-3)
- 3-Sialylgalactose sodium salt (CAS 83563-61-5)
- Fenticonazole EP Impurity B (CAS 80639-94-7)
- Methyl 3-amino-5,6-dimethylpyrazine-2-carboxylate (CAS 6294-72-0)
- Des-1-glycine-Terlipressin (CAS 14943-47-6)
- Dotinurad Impurity 51 (CAS CATO-C4X-249451)
- Caspofungin Impurity 48 (CAS CATO-C4X-157548)
- (R)-1-(5-Bromofuran-2-yl)ethan-1-ol (CAS 1568244-61-0)
- 1-Benzyl-5-methoxy-1,2,3,4-tetrahydronaphthalene (CAS 690232-04-3)
- Benz[j]aceanthrylene (CAS 202-33-5)
- (2E,3E)-3-Hydrazinylidene-1-(4-methoxyphenyl)-2-{2-[4-(trifluoromethyl)phenyl]hydrazin-1-ylidene}propan-1-one (CAS 338414-19-0)
- (D-Trp7,Ala8,D-Phe10)-α-MSH (6-11) amide (CAS 87616-84-0)
- Spectinomycin Dihydrochloride Pentahydrate (CAS 22189-32-8)
- Semaglutide impurity 251 (CAS CATO-C4X-2226251)
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