Tigecycline EP Impurity B CAS 149934-21-4
| CAS No. | 149934-21-4 |
| Molecular Formula | C23H28N4O7 |
| Molecular Weight | N/A |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
Under current pharmacopoeial and regulatory frameworks, quality-control requirements for this class of reference material explicitly involve the control of targets including Tigecycline EP Impurity B.
As a process- or degradation-related impurity, Tigecycline EP Impurity B (CAS 149934-21-4, C23H28N4O7HCl) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
Tigecycline EP Impurity B (C23H28N4O7HCl) contains a flavonoid core, an amide group, a hydroxyl group, an ether linkage, chlorine substitution. It is notably hygroscopic, halogen substitution raises its density and boiling point, the carboxyl group imparts weak acidity; these physicochemical properties determine the optimal preparation and storage of its standard solutions. 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.
As a certified reference material (CRM), Tigecycline EP Impurity B 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 | C23H28N4O7 HCl |
| Molecular Weight | 508.96 g/mol |
| Appearance | Pale yellow to yellow crystalline powder. (slight halide-like odor) |
| 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; Contains ester bond; hydrolyzes under strong alkaline conditions |
| Degree of Unsaturation (DBE) | 11.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 1999 |
| Halogen Content | Cl-containing |
| Nitrogen Atoms | 4 |
Related Tigecycline Standards
- Tigecycline mesylate, 98% (CAS 1135871-27-0)
- Tigecycline EP Impurity D(Tigecycline USP related compound A) (CAS 1138343-10-8)
- Tigecycline Hydrate (CAS 1229002-07-6)
- Tigecycline Impurity 7 (CAS 1268494-40-1)
- Tigecycline Impurity 22 Phosphate (CAS 1268494-40-1（free base）)
- Tigecycline Impurity 9 (CAS 1268494-46-7)
- Tigecycline Impurity 23 TFA (CAS 1268494-46-7（free base）)
- Tigecycline EP Impurity A (CAS 1422262-97-2)
Recommended Standards
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- tert-Butyl 1-oxo-1,2,3,4-tetrahydroisoquinoline-4-carboxylate (CAS 1956340-95-6)
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- 3-Chloro-6-(trifluoromethyl)pyridazin-4-amine (CAS 1894127-50-4)
- 3-Methoxy-1-methyl-1H-pyrazol-4-amine 4-methylbenzenesulfonate (CAS 2306263-39-6)
- Neuropeptide SF (human) (CAS 192387-39-6)
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