Simvastatin EP Impurity A-d6 Sodium Salt CAS 101314-97-0 (unlabelled)
| CAS No. | 101314-97-0 (unlabelled) |
| Molecular Formula | - |
| 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 Simvastatin EP Impurity A-d6 Sodium Salt.
Simvastatin EP Impurity A-d6 Sodium Salt (CAS 101314-97-0 (unlabelled)) is a certified pharmaceutical impurity reference standard with the molecular formula C25H33D6O6Na and a molecular weight of 464.61 g/mol.
Structurally, Simvastatin EP Impurity A-d6 Sodium Salt (C25H33D6O6Na) contains deuterium isotope labeling, a flavonoid core, a hydroxyl group, an ether linkage. The molecule exhibits a degree of unsaturation (DBE) of 9.5, corresponding to approximately 9 ring(s) or double-bond equivalent(s). With a molecular weight of 464.61 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 | C25H33D6O6 Na |
| Molecular Weight | 464.61 g/mol |
| Appearance | Pale yellow to yellow crystalline powder |
| Purity | >95% |
| 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) | 9.5 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
Related Simvastatin Standards
- Simvastatin D3 (CAS 1002347-61-6)
- Simvastatin-d6 (CAS 1002347-71-8)
- Simvastatin-d11 (CAS 1002347-74-1)
- Simvastatin EP Impurity A(Sodium Salt) (CAS 101314-97-0)
- Simvastatin impurity 01 (CAS 1092716-42-1)
- Simvastatin Impurity I (CAS 121624-18-8)
- Simvastatin Impurity 8 (CAS 130468-11-0)
- Simvastatin acid-d (CAS 1309272-51-2)
Recommended Standards
- Solifenacin EP impurity F HCl (CAS 180468-40-0)
- Butalbital Impurity 3 (CAS 53943-65-0)
- Tirofiban Impurity 88 (CAS CATO-C4X-125488)
- 5-methyl-5-(4-methylphenyl)imidazolidine-2,4-dione (CAS 23186-96-1)
- 3-Fluoro-5-(pyridin-3-yloxy)aniline, 97% (CAS 791644-59-2)
- 9-chloro-7-(nonan-5-yl)-1,2,3,4,4a,9b-hexahydrodibenzo[b,d]furan-4-ol (CAS CATO-C3D-262397)
- 4-(4-(4-Fluorophenyl)piperazin-1-yl)-6-methylpyrimidin-2-amine (CAS 873839-03-3)
- 4-(4-Chloro-2-ethylphenoxy)piperidinehydrochloride (CAS 1220030-97-6)
- (6-(tert-Butylamino)pyridin-3-yl)(phenyl)methanone (CAS 1355181-11-1)
- Semaglutide impurity 108 (CAS CATO-C4X-2226108)
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