Fluvastatin Impurity N1 CAS 194935-00-7
| CAS No. | 194935-00-7 |
| Molecular Formula | C28H34FNO4 |
| Molecular Weight | 467.57 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
The occurrence of Fluvastatin Impurity N1 is closely related to a steroid core, an amide group, a hydroxyl group, an ether linkage, fluorine substitution in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.
CATO supplies Fluvastatin Impurity N1 (CAS 194935-00-7), a pharmacopoeial impurity reference standard (molecular formula C28H34FNO4, MW 467.57 g/mol) used for the identification and quantification of trace impurities in APIs.
Fluvastatin Impurity N1 (C28H34FNO4) contains a steroid core, an amide group, a hydroxyl group, an ether linkage, fluorine substitution. Halogen substitution raises its density and boiling point, the carboxyl group imparts weak acidity; 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.
CATO manufactures Fluvastatin Impurity N1 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 | C28H34FNO4 |
| Molecular Weight | 467.57 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) | 12.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 2012 |
| Halogen Content | F-containing |
| Nitrogen Atoms | 1 |
Related Fluvastatin Standards
- Fluvastatin EP Impurity B (CAS 194934-96-8)
- Fluvastatin Alcohol Ketone (CAS 375846-25-6)
- Fluvastatin Methyl Ester (CAS 93957-53-0)
- Fluvastatin EP Impurity C(Sodium Salt) (CAS 2451176-31-9 (free acid))
- Fluvastatin Sodium - Impurity A (CAS 1025085-49-7)
- Fluvastatin Impurity 16 (CAS 2117644-62-7)
- Fluvastatin EP Impurity D (CAS 1160169-39-0)
- Fluvastatin EP Impurity C (CAS 2451176-31-9)
Recommended Standards
- (3S,5R,E)-tert-Butyl Fluvastatin (CAS 194935-03-0)
- Tetrapeptide-3 (CAS 827306-97-8)
- 2-((3-Ethyl-4-oxo-7-(p-tolyl)-3,4-dihydrothieno[3,2-d]pyrimidin-2-yl)thio)-N-(4-fluorobenzyl)acetamide (CAS 1040632-00-5)
- 5-Benzyloxy Rosiglitazone-d4 (CAS 1794768-28-7)
- Cefuroxime Sodium Impurity 29 (CAS CATO-C4X-124529)
- (1S,3S)-Tryptophan EP Impurity I (CAS 40678-46-4)
- Fesoterodine Impurity 7 (CAS CATO-C4X-16447)
- 6-Bromo-5-(difluoromethyl)-2-methylnicotinaldehyde (CAS 1804842-93-0)
- 7-Ethoxy-4-Methylcoumarin (CAS 87-05-8)
- 4-(bromomethyl)benzenesulfonic acid (CAS 82835-61-8)
- Methyl 4-(Trifluoromethoxy)indole-2-carboxylate (CAS 1154319-83-1)
- 2-(3-Chlorophenyl)benzo[d]thiazole (CAS 22868-31-1)
- 9,11-methane-epoxy Prostaglandin 1α (CAS 72517-81-8)
- Myosin Kinase Inhibiting Peptide (CAS 119386-39-9)
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