Pivmecillinam EP Impurity B CAS CATO-C4X-23232
| CAS No. | CATO-C4X-23232 |
| Molecular Formula | C21H35N3O6S |
| Molecular Weight | 457.58 g/mol |
| 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 Pivmecillinam EP Impurity B.
Pivmecillinam EP Impurity B (CAS CATO-C4X-23232) is a certified pharmaceutical impurity reference standard with the molecular formula C21H35N3O6S and a molecular weight of 457.58 g/mol.
Owing to a steroid core, an amide group, a sulfone group, a hydroxyl group, an ether linkage, Pivmecillinam EP Impurity B is typically off-white to pale yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 457.58 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.
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 | C21H35N3O6S |
| Molecular Weight | 457.58 g/mol |
| Purity | 97%+ |
| 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) | 6.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| Nitrogen Atoms | 3 |
| Sulfur Atoms | 1 |
Related Pivmecillinam Standards
- Pivmecillinam Impurity 11 (CAS CATO-C4X-232311)
- Pivmecillinam EP Impurity D (CAS CATO-C4X-23234)
- Pivmecillinam Impurity 9 (CAS CATO-C4X-23239)
- Pivmecillinam Impurity 12 (CAS CATO-C4X-232312)
- Pivmecillinam EP Impurity C (CAS CATO-C4X-23233)
- Pivmecillinam Impurity 13 (CAS CATO-C4X-232313)
- Pivmecillinam Impurity 5 (CAS 64527-05-5)
- Pivmecillinam Impurity 8 (CAS CATO-C4X-23238)
Recommended Standards
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- Biotin-PEG4-yne (CAS 1262681-31-1)
- Alverine EP Impurity D (CAS 2732347-30-5)
- Phenylephrine Impurity 45 (CAS 2491-37-4)
- Benzylpenicillin Impurity 84 (CAS CATO-C4X-189984)
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- Cyclopentanone-3,3,4,4-d4 (CAS 36219-23-5)
- Des-Ile12-Aib13-Tirzepatide (CAS CATO-CPTD788960)
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