| CAS No. | 65372-09-0 |
| Molecular Formula | C10H14O3 |
| Molecular Weight | 182.22 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
CATO manufactures Rosuvastatin Impurity 216 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.
CATO supplies Rosuvastatin Impurity 216 (CAS 65372-09-0), a pharmacopoeial impurity reference standard (molecular formula C10H14O3, MW 182.22 g/mol) used for the identification and quantification of trace impurities in APIs.
Owing to a carboxylic acid group, a hydroxyl group, an ether linkage, an aromatic ring system, Rosuvastatin Impurity 216 is typically off-white to pale yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 182.22 g/mol — guide the selection of appropriate sample preparation and analytical techniques. The high carbon-to-hydrogen ratio imparts good lipophilicity, allowing liquid-liquid extraction with non-polar solvents such as n-hexane or ethyl acetate.
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.
| Molecular Formula | C10H14O3 |
| Molecular Weight | 182.22 g/mol |
| Appearance | Off-white to pale yellow crystalline powder |
| Purity | >95% |
| Storage | Store at 2-8°C, keep sealed and dry |
| Solubility (reference) | Soluble in methanol, ethanol, DMSO |
| Stability | May oxidize slowly on prolonged air exposure; Hygroscopic; reseal immediately after opening |
| Degree of Unsaturation (DBE) | 4.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 1975 |