Oxytetracycline EP Impurity B CAS 60-54-8
| CAS No. | 60-54-8 |
| Molecular Formula | C22H24N2O8 |
| Molecular Weight | 444.43 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.
Oxytetracycline EP Impurity B (CAS 60-54-8) is a certified pharmaceutical impurity reference standard with the molecular formula C22H24N2O8 and a molecular weight of 444.43 g/mol.
Based on its molecular formula C22H24N2O8, Oxytetracycline EP Impurity B contains a flavonoid core, an amide group, a hydroxyl group, an ether linkage; these features give the compound characteristic absorption bands in UV spectroscopy. The molecular weight of 444.43 g/mol is directly relevant to the identification of the molecular ion in mass spectrometry. 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 | C22H24N2O8 |
| Molecular Weight | 444.43 g/mol |
| Appearance | Pale yellow to yellow crystalline powder |
| Purity | >95% |
| 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) | 12.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 1957 |
| Nitrogen Atoms | 2 |
Related Oxytetracycline Standards
- Oxytetracycline EP Impurity D (CAS 18695-01-7)
- Oxytetracycline EP Impurity E (CAS 18751-99-0)
- Oxytetracycline EP impurity F(Anhydrooxytetracycline) (CAS 4660-26-8)
- Oxytetracycline impurity 9 (CAS CATO-C4X-20139)
- Oxytetracycline EP Impurity C (CAS 7647-65-6)
- Oxytetracycline Hemicalcium Salt (CAS 15251-48-6)
- Oxytetracycline EP Impurity A (CAS 14206-58-7)
- Oxytetracycline-d6 (CAS CATO-CCAD303668)
Recommended Standards
- Doxycycline Impurity 8 (CAS CATO-C4X-19318)
- Tetracycline EP Impurity A (CAS 79-85-6)
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- Ixazomib Impurity 28 (CAS CATO-C4X-126728)
- Deferasirox EP Impurity C (CAS 201530-78-1)
- Avibactam Impurity 122 (CAS CATO-C4X-1348122)
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