Gemcitabine Impurity 5 CAS 2174019-90-8
| CAS No. | 2174019-90-8 |
| Molecular Formula | C16H15F2N3O5 |
| Molecular Weight | 367.30 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
Compared with other compounds in its class, the molecular weight of 367.30 g/mol gives Gemcitabine Impurity 5 distinctive chromatographic separation conditions and mass-spectrometry parameter settings.
Gemcitabine Impurity 5 (CAS 2174019-90-8) is a certified pharmaceutical impurity reference standard with the molecular formula C16H15F2N3O5 and a molecular weight of 367.30 g/mol.
Structurally, Gemcitabine Impurity 5 (C16H15F2N3O5) contains a flavonoid core, an amide group, a hydroxyl group, an ether linkage, fluorine substitution. The molecule exhibits a degree of unsaturation (DBE) of 10.0, corresponding to approximately 10 ring(s) or double-bond equivalent(s). With a molecular weight of 367.30 g/mol, it falls into the moderately-high-molecular-weight range. 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 | C16H15F2N3O5 |
| Molecular Weight | 367.30 g/mol |
| Appearance | Pale yellow to yellow crystalline powder. (slight halide-like odor, low volatility) |
| Purity | 97%+ |
| 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; Contains ester bond; hydrolyzes under strong alkaline conditions |
| Degree of Unsaturation (DBE) | 10.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 1998 |
| Halogen Content | F-containing |
| Nitrogen Atoms | 3 |
Related Gemcitabine Standards
- Gemcitabine Impurity 31 (CAS 142816-70-4)
- Gemcitabine Impurity N19 (CAS 1147182-15-7)
- Gemcitabine impurity 22 (CAS 143234-90-6)
- Gemcitabine Impurity 10 (CAS 1217452-91-9)
- Gemcitabine Impurity 17 (CAS 197452-15-6)
- Gemcitabine Impurity 29 (CAS 122111-02-8)
- Gemcitabine Impurity 32 (CAS 122111-01-7)
- Gemcitabine Impurity 16 (CAS 1173824-58-2)
Recommended Standards
- [(2R,3S,5R)-5-(2-amino-6-oxo-1H-purin-9-yl)-3-methoxy-tetrahydrofuran-2-yl]methyl dihydrogen phosphate (CAS 73646-17-0)
- (4-(Methylselanyl)phenyl)(3,4,5-trimethoxyphenyl)methanol (CAS 2123478-18-0)
- 4-(((2R,3S,4R,5R)-5-(6-Amino-9H-purin-9-yl)-3,4-dihydroxytetrahydrofuran-2-yl)methoxy)-4-oxobutanoic Acid (CAS 102029-71-0)
- (2R,3R,4R,5R)-4-(((2S,3R,4S,5S,6R)-6-(azidomethyl)-3,4,5-trihydroxytetrahydro-2H-pyran-2-yl)oxy)-2,3,5,6-tetrahydroxyhexanal (CAS 1499187-31-3)
- Ibrutinib Impurity 33 (CAS CATO-C4X-106433)
- Fudosteine impurity 50 (CAS CATO-C4X-144750)
- Fudosteine Impurity 49 (CAS CATO-C4X-144749)
- 4-Bromo-3-(difluoromethyl)-5-iodopyridin-2-amine (CAS 1806801-69-3)
- 2-Amino-4,5-dichloropyridine (CAS 188577-68-6)
- 2-(Difluoromethyl)-6-iodo-3-methoxypyridine (CAS 1806780-81-3)
- 4-Iodo-N-phenylaniline (CAS 74686-56-9)
- (3R,4S)-Benzyl 3-fluoro-4-hydroxypiperidine-1-carboxylate (CAS 1147112-66-0)
- Benzyl 2-amino-8-azaspiro[4.5]Decane-8-carboxylate (CAS 1823270-06-9)
- [a-Glu](Side chain transposition)- Semaglutide (CAS CATO-C4X-2226111)
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