Simvastatin EP Impurity M CAS 864357-87-9
| CAS No. | 864357-87-9 |
| Molecular Formula | C27H44O6 |
| Molecular Weight | 464.63 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
CATO supplies Simvastatin EP Impurity M (CAS 864357-87-9), a pharmacopoeial impurity reference standard (molecular formula C27H44O6, MW 464.63 g/mol) used for the identification and quantification of trace impurities in APIs.
Structurally, Simvastatin EP Impurity M (C27H44O6) contains a steroid core, a hydroxyl group, an ether linkage. The molecule exhibits a degree of unsaturation (DBE) of 6.0, corresponding to approximately 6 ring(s) or double-bond equivalent(s). With a molecular weight of 464.63 g/mol, it falls into the moderately-high-molecular-weight range. 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 | C27H44O6 |
| Molecular Weight | 464.63 g/mol |
| Appearance | Off-white to pale yellow crystalline powder |
| 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 |
| Degree of Unsaturation (DBE) | 6.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 1987 |
Related Simvastatin Standards
- Simvastatin Impurity M (CAS 1796930-96-5)
- Simvastatin EP Impurity B (CAS 145576-25-6)
- Simvastatin acid-d (CAS 1309272-51-2)
- Simvastatin Methyl Ester (CAS 145576-26-7)
- Simvastatin impurity 01 (CAS 1092716-42-1)
- Simvastatin EP Impurity J (CAS 864357-88-0)
- Simvastatin EP Impurity N (Mixture of Diastereomers) (CAS 774611-54-0)
- Simvastatin Impurity 8 (CAS 130468-11-0)
Recommended Standards
- Muricholic Acid Impurity 22 (CAS 111824-32-9)
- U 73122 (CAS 112648-68-7)
- methyl cholate 3-acetate (CAS 7443-91-6)
- Lanosta-7,9(11),23,25(27)-tetraen-26-oic acid, 23,27-epoxy-3-oxo- (CAS 130825-80-8)
- Irinotecan Impurity 72 (CAS 100286-93-9)
- Amifostine Impurity 7 (CAS 4461-39-6)
- Ketorolac Impurity 33 (CAS CATO-C4X-166933)
- 3-{[(3,5-Difluorobenzyl)oxy]methyl}pyrrolidinehydrochloride (CAS 1219976-59-6)
- 3-(3-Imino-5-methyl-2,3-dihydro-1h-pyrazol-1-yl)propanoic acid (CAS 1006486-08-3)
- 2-Bromo-4-fluoro-1-(2,2,2-trifluoroethyl)-benzene (CAS 1186194-81-9)
- Oseltamivir EP Impurity B (CAS 2125702-80-7)
- 4-Fluoro-2-(pyridin-4-yl)benzaldehyde (CAS 1214380-05-8)
- 6-Bromo-4-(difluoromethyl)-5-methylpicolinonitrile (CAS 1805439-19-3)
- Neuropeptide Y, porcine (CAS 82785-45-3)
Why CATO?
- ISO 17034 accredited reference material producer (CNAS + ANAB dual accreditation)
- 130,000+ catalog items in stock, COA supplied with every batch
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- Technical support: +86 18665070610 / Nicole.chen@cato-chem.com