Pimecrolimus Impurity 13 CAS CATO-C4X-173113
| CAS No. | CATO-C4X-173113 |
| Molecular Formula | C43H68ClNO11 |
| Molecular Weight | 810.45 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
Pimecrolimus Impurity 13 (CAS CATO-C4X-173113) is a certified pharmaceutical impurity reference standard with the molecular formula C43H68ClNO11 and a molecular weight of 810.45 g/mol.
The molecular framework of Pimecrolimus Impurity 13 (C43H68ClNO11) is characterized by a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage, chlorine substitution. In reversed-phase chromatography, its retention is governed primarily by the protonation state of its nitrogen-containing groups, which provides a practical basis for HPLC-UV/DAD or LC-MS method development. Halogen substitution (F/Cl/Br/I) produces a distinctive isotope pattern in mass spectrometry, a valuable aid for qualitative confirmation.
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.
As a certified reference material (CRM), Pimecrolimus Impurity 13 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 | C43H68ClNO11 |
| Molecular Weight | 810.45 g/mol |
| Purity | >80% |
| 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) | 10.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| Halogen Content | Cl-containing |
| Nitrogen Atoms | 1 |
Related Pimecrolimus Standards
- Pimecrolimus (CAS 137071-32-0)
- Pimecrolimus Impurity 12 (CAS CATO-C4X-173112)
- Pimecrolimus Impurity 14 (CAS CATO-C4X-173114)
- Pimecrolimus Impurity 16 (CAS CATO-C4X-173116)
- Pimecrolimus Impurity 17 (CAS CATO-C4X-173117)
- Pimecrolimus Impurity 19 (CAS CATO-C4X-173119)
- Pimecrolimus Impurity 2 (CAS CATO-C4X-17312)
- Pimecrolimus Impurity 3 (CAS CATO-C4X-17313)
Recommended Standards
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