Simvastatin EP Impurity K CAS CATO-C4X-119913
| CAS No. | CATO-C4X-119913 |
| Molecular Formula | C25H40O5 |
| Molecular Weight | 420.58 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 Simvastatin EP Impurity K.
CATO supplies Simvastatin EP Impurity K (CAS CATO-C4X-119913), a pharmacopoeial impurity reference standard (molecular formula C25H40O5, MW 420.58 g/mol) used for the identification and quantification of trace impurities in APIs.
The molecular framework of Simvastatin EP Impurity K (C25H40O5) is characterized by a steroid core, a hydroxyl group, an ether linkage. In reversed-phase chromatography, its retention is governed primarily by the polarity and ionization state of its functional groups, which provides a practical basis for HPLC-UV/DAD or LC-MS method development. The aromatic system may exhibit native fluorescence, enabling detection with a fluorescence detector (FLD).
Recommended for quantitative analysis by HPLC, GC, LC-MS/MS, or GC-MS as an external calibration standard; it can also be used for spiked-recovery experiments, LOD/LOQ determination, and LC-MS/MS multiple-reaction-monitoring (MRM) calibration.
As a certified reference material (CRM), Simvastatin EP Impurity K 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 | C25H40O5 |
| Molecular Weight | 420.58 g/mol |
| Appearance | Off-white to pale 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) | 6.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
Related Simvastatin Standards
- Simvastatin Impurity 26 (CAS CATO-C4X-119926)
- Simvastatin Impurity 27 (CAS 132487-01-5)
- Simvastatin impurity 30 (CAS 92083-03-9)
- Simvastatin D3 (CAS 1002347-61-6)
- Simvastatin (CAS 79902-63-9)
- Simvastatin-d6 (CAS 1002347-71-8)
- Simvastatin Impurity I (CAS 121624-18-8)
- Simvastatin EP Impurity G (CAS 1449248-72-9)
Recommended Standards
- Resin acids and Rosin acids, hydrogenated, esters with pentaerythritol (CAS 64365-17-9)
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- Cholic Acid Impurity N77 (CAS 14772-99-7)
- (5|A,7|A,12|A)-7,12-Dihydroxy-3-oxo-cholan-24-oic Acid Methyl Ester 14772-92-0 7|A,12|A-Dihydroxy-3-oxo-5|A-cholan-24-oic Acid Methyl Ester Methyl 3-Keto-7|A,12|A-dihydroxy-5|A-cholanoate (CAS 14772-92-0)
- Argatroban Impurity 45 (CAS CATO-C4X-100745)
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- 7-Fluoro-8-methylquinazoline (CAS 2842055-47-2)
- 6-Bromo-7-butoxy-2-oxo-2H-chromene-3-carboxylic acid (CAS 1352512-74-3)
- 4-Ethyl-1H-pyrrole-2-carbaldehyde (CAS 187842-17-7)
- (S)-2-Amino-N-(2,6-dichlorobenzyl)-N-ethylpropanamide (CAS 1353993-37-9)
- Insulin Degludec Impurity 17 (CAS CATO-C4X-215717)
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