Pilocarpine Hydrochloride EP Impurity B CAS 28406-15-7
| CAS No. | 28406-15-7 |
| Molecular Formula | C11H18N2O3 |
| Molecular Weight | 226.27 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
As a process- or degradation-related impurity, Pilocarpine Hydrochloride EP Impurity B (CAS 28406-15-7, C11H18N2O3) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
Based on its molecular formula C11H18N2O3, Pilocarpine Hydrochloride EP Impurity B contains an amino-acid-derived structure, an amide group, a hydroxyl group, an ether linkage; these features give the compound characteristic absorption bands in UV spectroscopy. The molecular weight of 226.27 g/mol is directly relevant to the identification of the molecular ion in mass spectrometry. 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), Pilocarpine Hydrochloride 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 | C11H18N2O3 |
| Molecular Weight | 226.27 g/mol |
| Appearance | Off-white to pale yellow crystalline powder |
| Purity | 97%+ |
| Storage | Store at 2-8°C, protect from light, keep sealed and dry |
| Solubility (reference) | Soluble in methanol, ethanol, DMSO |
| Stability | May oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light; Hygroscopic; reseal immediately after opening |
| Degree of Unsaturation (DBE) | 4.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 1965 |
| Nitrogen Atoms | 2 |
Related Pilocarpine Standards
- Pilocarpine Hydrochloride EP Impurity C (CAS 34350-99-7)
- Pilocarpine Impurity 20 (CAS CATO-C4X-240120)
- Pilocarpine Impurity 18 (CAS CATO-C4X-240118)
- Pilocarpine Impurity 22 (CAS CATO-C4X-240122)
- Pilocarpine Impurity 4 (CAS CATO-C4X-24014)
- Pilocarpine Impurity 11 (CAS CATO-C4X-240111)
- Pilocarpine (CAS 92-13-7)
- Pilocarpine EP Impurity B Sodium Salt (CAS 92598-79-3)
Recommended Standards
- Ph-PEG3 (CAS 7204-16-2)
- Phenacetin Impurity 8 (CAS 7466-38-8)
- Potassium L-(+)-tartrate (CAS 921-53-9)
- N'-methyl-N'-phenylbenzohydrazide (CAS 52023-39-9)
- Drotaverine Impurity 7 (CAS CATO-C4X-24357)
- Lercanidipine Impurity 27 (CAS 2250243-16-2)
- Tofacitinib Impurity 171 (CAS CATO-C4X-1079171)
- 1-(2-(Methylthio)pyrimidin-4-yl)piperidin-4-amine hydrochloride (CAS 1261230-78-7)
- Tert-butyl 5-bromo-6-(trifluoromethoxy)indole-1-carboxylate (CAS 2227479-96-9)
- Cinacalcet Impurity 65 (CAS 1860814-97-6)
- Methyl 2-(2-((4-fluorophenyl)sulfonamido)thiazol-4-yl)acetate (CAS 929866-40-0)
- 3-[1-(tert-butoxycarbonylamino)cyclopropyl]prop-2-ynoic acid (CAS 1268810-10-1)
- 3-(Benzyloxy)-1H-pyrrole-2-carbaldehyde (CAS 56164-40-0)
- Semaglutide Impurity 129 (CAS 2490269-79-7)
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