Gemcitabine EP Impurity B HCl CAS 122111-05-1
| CAS No. | 122111-05-1 |
| Molecular Formula | C9H11F2N3O4 |
| Molecular Weight | N/A |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
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.
CATO supplies Gemcitabine EP Impurity B HCl (CAS 122111-05-1), a pharmacopoeial impurity reference standard (molecular formula C9H11F2N3O4HCl, MW 299.66 g/mol) used for the identification and quantification of trace impurities in APIs.
Based on its molecular formula C9H11F2N3O4HCl, Gemcitabine EP Impurity B HCl contains a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage, fluorine/chlorine substitution; these features give the compound characteristic absorption bands in UV spectroscopy. The molecular weight of 299.66 g/mol is directly relevant to the identification of the molecular ion in mass spectrometry. Nitrogen-containing functional groups confer excellent ionization efficiency in positive-ion electrospray (ESI) mode, making the compound well suited to LC-MS/MS analysis.
CATO manufactures Gemcitabine EP Impurity B HCl under ISO 17034:2016 accreditation with dual CNAS and ANAB accreditation. Each batch is characterized by orthogonal methods and supplied with a full Certificate of Analysis (COA), ensuring metrological traceability.
Physical & Chemical Properties
| Molecular Formula | C9H11F2N3O4 HCl |
| Molecular Weight | 299.66 g/mol |
| Appearance | Off-white to pale yellow crystalline powder. (slight halide-like odor, faint amine-like odor, low volatility) |
| Purity | 97%+ |
| Storage | Store at 2-8°C, protect from light, keep sealed and dry, keep tightly closed to prevent evaporation |
| Solubility (reference) | Soluble in methanol, ethanol, DMSO |
| 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) | 4.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 1991 |
| Halogen Content | F/Cl-containing |
| Nitrogen Atoms | 3 |
Related Gemcitabine Standards
- Gemcitabine Impurity N1 (CAS 103882-85-5)
- Gemcitabine Triphosphate trisodium salt (CAS 110988-86-8(free acid))
- Gemcitabine EP Impurity C (CAS 114248-23-6)
- Gemcitabine Impurity N19 (CAS 1147182-15-7)
- Gemcitabine Impurity 20 (CAS 116371-66-5)
- Gemcitabine Monophosphate (CAS 116371-67-6)
- Gemcitabine Impurity 16 (CAS 1173824-58-2)
- Gemcitabine Impurity 10 (CAS 1217452-91-9)
Recommended Standards
- Avatrombopag impurity 124 (CAS CATO-C4X-2234124)
- Sodium Cromoglicate Impurity 24 (CAS CATO-C4X-201124)
- Papaverine EP Impurity C HCl (3,4-Dihydropapaverine HCl) (CAS 5884-22-0)
- 2-Isopropyl-4-(1,2,3,4-tetrahydroisoquinolin-7-yl)thiazole (CAS 1365940-77-7)
- 6-Amino-2-(isopentylthio)pyrimidin-4(1H)-one (CAS 62459-18-1)
- {[(4-Nitrophenyl)methyl]sulfanyl}methanimidamide hydrobromide (CAS 64039-36-7)
- 2-((4-Chlorophenyl)thio)ethan-1-ol (CAS 13457-98-2)
- N-(3,4-Dimethoxyphenyl)pyrazine-2-carboxamide (CAS 717868-49-0)
- (S)-2-((((9H-fluoren-9-yl)methoxy)carbonyl)amino)-2-(thiophen-2-yl)acetic acid (CAS 211682-13-2)
- Peptide 436 (CAS CATO-CPTD788436)
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