Clarithromycin Impurity 19 CAS CATO-C4X-100219
| CAS No. | CATO-C4X-100219 |
| Molecular Formula | C38H69NO14 |
| Molecular Weight | 763.95 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
Clarithromycin Impurity 19 (CAS CATO-C4X-100219) is a certified pharmaceutical impurity reference standard with the molecular formula C38H69NO14 and a molecular weight of 763.95 g/mol.
The molecular framework of Clarithromycin Impurity 19 (C38H69NO14) is characterized by a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage. 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. The aromatic system may exhibit native fluorescence, enabling detection with a fluorescence detector (FLD).
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 | C38H69NO14 |
| Molecular Weight | 763.95 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) | 5.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| Nitrogen Atoms | 1 |
Related Clarithromycin Standards
- Clarithromycin EP Impurity A (CAS 124412-58-4)
- Clarithromycin Impurity 20 (CAS 118074-07-0)
- Clarithromycin 9-Oxime (CAS 103450-87-9)
- Clarithromycin EP Impurity C (CAS 127253-06-9)
- Clarithromycin EP Impurity L (CAS 127253-05-8)
- Clarithromycin EP Impurity E (CAS 81103-14-2)
- Clarithromycin EP Impurity F (CAS 128940-83-0)
- Clarithromycin EP Impurity P (CAS 123967-58-8)
Recommended Standards
- 5-oxo-l-prolyl-l-phenylalanyl-l-phenylalanyl-l-prolyl-l-leucyl-l-methioninamide 83929-84-4 AR-1G9331 (CAS 83929-84-4)
- (14R)-Hydroxy Clarithromycin (CAS 116836-41-0)
- N4-Benzoyl-2-O-tert-butyldimethylsilyl-5-O-DMT-cytidine (CAS 81256-87-3)
- (Pyr6,Pro9)-Substance P (6-11) (CAS 79775-19-2)
- Tropicamide EP Impurity A (CAS 33403-97-3)
- Canagliflozin Impurity 106 (CAS CATO-C4X-1123106)
- Difamilast Impurity 3 (CAS 937782-02-0)
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