Clarithromycin EP Impurity L CAS 127253-05-8
| CAS No. | 127253-05-8 |
| Molecular Formula | C38H70N2O13 |
| Molecular Weight | 762.97 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
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.
Clarithromycin EP Impurity L (CAS 127253-05-8) is a certified pharmaceutical impurity reference standard with the molecular formula C38H70N2O13 and a molecular weight of 762.97 g/mol.
Owing to a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage, Clarithromycin EP Impurity L is typically off-white to pale yellow amorphous powder. Its solid-state physicochemical attributes — including a molecular weight of 762.97 g/mol — guide the selection of appropriate sample preparation and analytical techniques. 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).
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.
Physical & Chemical Properties
| Molecular Formula | C38H70N2O13 |
| Molecular Weight | 762.97 g/mol |
| Purity | >90% |
| Storage | Store in a cool place (≤25°C), protect from light, keep sealed and dry |
| Solubility (reference) | Soluble in DMSO, DMF, methanol |
| Stability | May oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light; Hygroscopic; reseal immediately after opening |
| Degree of Unsaturation (DBE) | 5.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 1993 |
| Nitrogen Atoms | 2 |
Related Clarithromycin Standards
- Clarithromycin 9-Oxime (CAS 103450-87-9)
- Clarithromycin EP Impurity C (CAS 127253-06-9)
- Clarithromycin EP Impurity A (CAS 124412-58-4)
- Clarithromycin Impurity 19 (CAS CATO-C4X-100219)
- Clarithromycin Impurity 20 (CAS 118074-07-0)
- 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
- Azithromycin EP Impurity K (CAS 612534-95-9)
- Erythromycin Methyloxime（E） (CAS CATO-C4X-100132)
- Azithromycin EP Impurity F (CAS 612069-28-0)
- Erythromycin Impurity 12 (CAS CATO-C4X-100112)
- Ketorolac Impurity 30 (CAS CATO-C4X-166930)
- Rasagiline Impurity 26 HCl (CAS CATO-C4X-191326)
- Ondansetron Impurity 14 (CAS 30354-18-8)
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- Methyl 5-bromo-2,6-dichloronicotinate (CAS 1823373-59-6)
- Doxofylline Impurity 15 (CAS CATO-C4X-151315)
- Alogliptin Impurity 10 (CAS CATO-C4X-109910)
- 2,3-Phenazinediol (CAS 19220-18-9)
- 4-(1-Benzylpyrrolidin-3-yl)morpholine (CAS 1245646-52-9)
- Semaglutide impurity 255 (CAS CATO-C4X-2226255)
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