Pitavastatin Impurity N2 CAS 167073-19-0
| CAS No. | 167073-19-0 |
| Molecular Formula | C27H28FNO4 |
| Molecular Weight | 449.51 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 Pitavastatin Impurity N2.
Pitavastatin Impurity N2 (CAS 167073-19-0) is a certified pharmaceutical impurity reference standard with the molecular formula C27H28FNO4 and a molecular weight of 449.51 g/mol.
Based on its molecular formula C27H28FNO4, Pitavastatin Impurity N2 contains a steroid core, an amide group, a hydroxyl group, an ether linkage, fluorine substitution; these features give the compound characteristic absorption bands in UV spectroscopy. The molecular weight of 449.51 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.
As a certified reference material (CRM), Pitavastatin Impurity N2 meets the metrological traceability requirements of ISO/IEC 17025 laboratories. Batch-to-batch consistency is monitored via control charts to guarantee comparable assigned values across lots.
Physical & Chemical Properties
| Molecular Formula | C27H28FNO4 |
| Molecular Weight | 449.51 g/mol |
| Appearance | Pale yellow to yellow crystalline powder. (slight halide-like odor) |
| Purity | 97%+ |
| Storage | Store at room temperature, protect from light, keep sealed and dry |
| Solubility (reference) | Soluble in methanol, acetonitrile, DMSO, water (slightly soluble) |
| Stability | May oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light; Contains ester bond; hydrolyzes under strong alkaline conditions |
| Degree of Unsaturation (DBE) | 14.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 2004 |
| Halogen Content | F-containing |
| Nitrogen Atoms | 1 |
Related Pitavastatin Standards
- Pitavastatin Ethyl Ester (CAS 172336-32-2)
- Pitavastatin Impurity 110 (CAS CATO-C4X-1037110)
- Pitavastatin Impurity 6 (CAS 172336-33-3)
- Pitavastatin 3-Oxo Ethyl Ester (CAS 148901-69-3)
- Pitavastatin Impurity 109 (CAS CATO-C4X-1037109)
- Pitavastatin Impurity 135 (CAS CATO-C4X-1037135)
- Pitavastatin Impurity 51 (CAS 1187966-93-3)
- Pitavastatin Impurity 69 (CAS CATO-C4X-103769)
Recommended Standards
- (E)-Ethyl 7-(2-cyclopropyl-4-(4-fluorophenyl)-quinolin-3-yl)-3,5-dihydroxyhept-6-enoate (CAS 147008-20-6)
- Ac-Val-Tyr-Lys-NH2 (CAS 884009-99-8)
- 2-Ethoxy-d5-1-[[2'-[(hydroxyamino)iminomethyl][1,1'-biphenyl]-4-yl]methyl]-1H-benzimidazole-7-carboxylic Acid Methyl Ester (CAS 1795133-18-4)
- Hyoscyamine Impurity 13 (CAS CATO-C4X-343713)
- Crisaborole lmpurity 76 (CAS 2227126-09-0)
- Cefmetazole Impurity 56 (CAS CATO-C4X-150756)
- Abiraterone Impurity 63 (CAS CATO-C4X-107063)
- 4-((m-Tolyloxy)methyl)piperidine (CAS 63608-41-3)
- 4-Hydroxy-6-phenethyl-2H-pyran-2-one (CAS 33253-32-6)
- (4-Chlorophenyl)(5-hydroxycyclopent-1-en-1-yl)methanone (CAS 88738-08-3)
- 1-Phenyl-5-(propan-2-yl)-1h-pyrazole-3-carboxylic acid (CAS 3191-87-5)
- 4,5-Dihydro-1H-1,5-methanobenzo[d]azepin-2(3H)-one (CAS 357426-13-2)
- 2,3-Dihydro-1H-benzo[d]imidazole-5-carboxylic acid (CAS 851669-20-0)
- Semaglutide impurity 66 (CAS CATO-C4X-222666)
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