Josamycin EP Impurity J CAS CATO-C4X-301512
| CAS No. | CATO-C4X-301512 |
| Molecular Formula | C43H71NO15 |
| Molecular Weight | 842.02 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
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 process- or degradation-related impurity, Josamycin EP Impurity J (CAS CATO-C4X-301512, C43H71NO15) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
Josamycin EP Impurity J (C43H71NO15) contains a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage. The carboxyl group imparts weak acidity; these physicochemical properties determine the optimal preparation and storage of its standard solutions. 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).
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 | C43H71NO15 |
| Molecular Weight | 842.02 g/mol |
| 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) | 9.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| Nitrogen Atoms | 1 |
Related Josamycin Standards
- Josamycin EP Impurity E (Platenomycin A1) (CAS 40615-47-2)
- Josamycin Impurity 7 (CAS CATO-C4X-30157)
- Josamycin EP Impurity B (18-Dihydroleucomycin A3) (CAS 40361-41-9)
- Josamycin EP Impurity D (Isoleucomycin A3) (CAS 22340-94-9)
- Josamycin Impurity 8 (CAS CATO-C4X-30158)
- Josamycin EP Impurity A (CAS 18361-46-1)
- Josamycin Propionate - API Standards (CAS 40922-77-8)
- Josamycin Impurity 11 (CAS 31674-19-8)
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