Gemcitabine Impurity 36 CAS 166376-97-2
| CAS No. | 166376-97-2 |
| Molecular Formula | C10H16F2O5 |
| Molecular Weight | 254.23 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
Under current pharmacopoeial and regulatory frameworks, quality-control requirements for this class of reference material explicitly involve the control of targets including Gemcitabine Impurity 36.
Gemcitabine Impurity 36 (CAS 166376-97-2) is a certified pharmaceutical impurity reference standard with the molecular formula C10H16F2O5 and a molecular weight of 254.23 g/mol.
Based on its molecular formula C10H16F2O5, Gemcitabine Impurity 36 contains a carboxylic acid group, a hydroxyl group, an ether linkage, fluorine substitution; these features give the compound characteristic functional-group stretching vibrations in infrared spectroscopy. The molecular weight of 254.23 g/mol is directly relevant to the identification of the molecular ion in mass spectrometry. 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 | C10H16F2O5 |
| Molecular Weight | 254.23 g/mol |
| Purity | 97%+ |
| Storage | Store in a cool place (≤25°C), keep sealed and dry, keep tightly closed to prevent evaporation |
| Solubility (reference) | Soluble in methanol, ethanol, DMSO |
| Stability | Hygroscopic; reseal immediately after opening; Contains ester bond; hydrolyzes under strong alkaline conditions |
| Degree of Unsaturation (DBE) | 2.0 |
| CAS Registry Year (est.) | 2004 |
| Halogen Content | F-containing |
Related Gemcitabine Standards
- Gemcitabine Impurity N2 (CAS 928797-50-6)
- Gemcitabine Impurity 17 (CAS 95058-92-7)
- Gemcitabine Impurity 23 (CAS 82188-74-7)
- Gemcitabine Impurity N1 (CAS 103882-85-5)
- Gemcitabine (CAS 95058-81-4)
- Gemcitabine EP Impurity B (CAS 95058-85-8)
- Gemcitabine Impurity 14 (CAS 294177-31-4)
- Gemcitabine Impurity 20 (CAS 153381-14-7)
Recommended Standards
- Paliperidone Impurity 154 (CAS CATO-C4X-1724154)
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- Levocabastine impurity 23 (CAS CATO-C4X-228923)
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