Clarithromycin EP Impurity H CAS 127140-69-6
| CAS No. | 127140-69-6 |
| Molecular Formula | C38H67NO14 |
| Molecular Weight | 761.94 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
Owing to a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage, Clarithromycin EP Impurity H is typically off-white to pale yellow amorphous powder. Its solid-state physicochemical attributes — including a molecular weight of 761.94 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).
CATO supplies Clarithromycin EP Impurity H (CAS 127140-69-6), a pharmacopoeial impurity reference standard (molecular formula C38H67NO14, MW 761.94 g/mol) used for the identification and quantification of trace impurities in APIs.
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), Clarithromycin EP Impurity H 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 | C38H67NO14 |
| Molecular Weight | 761.94 g/mol |
| Purity | >90% |
| 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) | 6.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 1993 |
| Nitrogen Atoms | 1 |
Related Clarithromycin Standards
- Clarithromycin EP Impurity E (CAS 81103-14-2)
- Clarithromycin EP Impurity F (CAS 128940-83-0)
- Clarithromycin EP Impurity P (CAS 123967-58-8)
- Clarithromycin Impurity 21 (CAS CATO-C4X-100221)
- 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 A (CAS 124412-58-4)
Recommended Standards
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