Orforglipron impurity 23 CAS 2212021-40-2
| CAS No. | 2212021-40-2 |
| Molecular Formula | C8H11FN2 |
| Molecular Weight | N/A |
| 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 Orforglipron impurity 23.
Orforglipron impurity 23 (CAS 2212021-40-2) is a certified pharmaceutical impurity reference standard with the molecular formula C8H11FN2HCl and a molecular weight of 190.65 g/mol.
Orforglipron impurity 23 (C8H11FN2HCl) contains a nitrile group, fluorine/chlorine substitution. Halogen substitution raises its density and boiling point; 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.
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 | C8H11FN2 HCl |
| Molecular Weight | 190.65 g/mol |
| Appearance | 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 tightly closed to prevent evaporation |
| Solubility (reference) | Soluble in DMSO, DMF, methanol |
| Stability | May oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light |
| Degree of Unsaturation (DBE) | 3.0 |
| UV Absorption | UV-absorbing |
| CAS Registry Year (est.) | 1998 |
| Halogen Content | F/Cl-containing |
| Nitrogen Atoms | 2 |
Related Orforglipron Standards
- Orforglipron impurity 36 (CAS 1092961-07-3)
- Orforglipron Impurity 43 (CAS 2025595-61-1(free base))
- Orforglipron Impurity 54 (CAS 210536-89-3)
- Orforglipron impurity 127 (CAS 2203400-61-5)
- Orforglipron Impurity 60 (CAS 2212020-29-4)
- Orforglipron (CAS 2212020-52-3)
- Orforglipron impurity 121 (CAS 2212021-39-9)
- Orforglipron Impurity 63 (CAS 2212021-57-1)
Recommended Standards
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- 6,7-Diaminoquinoxaline-2,3-dione DiHCl (CAS 17498-26-9)
- (3S,4S)-4-((tert-butoxycarbonyl)amino)tetrahydrofuran-3-carboxylic acid (CAS 2165596-62-1)
- 2,3,6-TRIMETHYLPHENOXY)ACETIC ACID (CAS 104295-97-8)
- 2-Methoxy-N-((3-methyl-1-propyl-1H-pyrazol-4-yl)methyl)ethan-1-amine hydrochloride (CAS 1856029-74-7)
- Glucagon-like peptide 2 (CAS 89750-15-2)
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