| CAS No. | 33386-20-8(Free Amide) |
| Molecular Formula | C12H21N5 |
| Molecular Weight | N/A |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
The occurrence of Tandospirone Impurity 9 HCl is closely related to a nitrogen-containing heterocyclic scaffold, a nitrile group, chlorine substitution in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.
Tandospirone Impurity 9 HCl (CAS 33386-20-8(Free Amide)) is a certified pharmaceutical impurity reference standard with the molecular formula C12H21N5HCl and a molecular weight of 271.79 g/mol.
Tandospirone Impurity 9 HCl (C12H21N5HCl) contains a nitrogen-containing heterocyclic scaffold, a nitrile group, chlorine substitution. Halogen substitution raises its density and boiling point; these physicochemical properties determine the optimal preparation and storage of its standard solutions. 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.
| Molecular Formula | C12H21N5 2*HCl |
| Molecular Weight | 271.79 g/mol |
| Purity | >95% |
| 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) | 4.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| Halogen Content | Cl-containing |
| Nitrogen Atoms | 5 |