Clopidogrel EP Impurity B HCl CAS 1396607-35-4
| CAS No. | 1396607-35-4 |
| Molecular Formula | C16H16ClNO2S |
| Molecular Weight | N/A |
| 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.
As a process- or degradation-related impurity, Clopidogrel EP Impurity B HCl (CAS 1396607-35-4, C16H16ClNO2SHCl) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
The molecular framework of Clopidogrel EP Impurity B HCl (C16H16ClNO2SHCl) is characterized by a nitrogen-containing heterocyclic scaffold, an amide group, a sulfone group, a hydroxyl group, an ether linkage, chlorine substitution. In reversed-phase chromatography, its retention is governed primarily by its high hydrophobicity (logP), which provides a practical basis for HPLC-UV/DAD or LC-MS method development. Halogen substitution (F/Cl/Br/I) produces a distinctive isotope pattern in mass spectrometry, a valuable aid for qualitative confirmation.
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 | C16H16ClNO2S HCl |
| Molecular Weight | 358.28 g/mol |
| Purity | 97%+ |
| Storage | Store at 2-8°C, protect from light |
| Solubility (reference) | Soluble in chloroform, dichloromethane, ethyl acetate, DMSO |
| Stability | May oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light; Contains ester bond; hydrolyzes under strong alkaline conditions |
| Degree of Unsaturation (DBE) | 8.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 1991 |
| Halogen Content | Cl-containing |
| Nitrogen Atoms | 1 |
| Sulfur Atoms | 1 |
Related Clopidogrel Standards
- Clopidogrel Impurity 74 (CAS 1008008-56-7)
- Clopidogrel Impurity 82 (CAS 1015247-87-6)
- rac-Clopidogrel EP Impurity A HCl (CAS 1015247-88-7)
- rac Clopidogrel [(tert-Butylcarbonyl)oxy]methyl ester (CAS 1043913-82-1)
- 2-Oxo Clopidogrel (Mixture of Diastereomers) (CAS 109904-27-0)
- Clopidogrel Impurity 42 (CAS 109904-36-1)
- cis-Clopidogrel glutathione disulfide, mixture of diastereomers (CAS 1118605-95-0)
- Clopidogrel Impurity 48 (CAS 111954-31-5)
Recommended Standards
- Agomelatine impurity 40 (CAS CATO-C4X-110840)
- Mosapride Impurity 54 (CAS CATO-C4X-104454)
- Suzetrigine Impurity 53 (CAS CATO-C4X-336953)
- 2-(Tetrahydro-2h-pyran-2-yl)ethanethioamide (CAS 1154976-90-5)
- 2-{[(tert-butoxy)carbonyl]amino}cyclooctane-1-carboxylic acid (CAS 1307308-65-1)
- Ethyl (5-bromo-2,3-dioxo-2,3-dihydro-1H-indol-1-yl)acetate (CAS 754235-62-6)
- Benzyl 1,8-diazaspiro[5.5]Undecane-8-carboxylate hydrochloride (CAS 1439896-71-5)
- 3-(3-Ethoxy-4-methoxybenzyl)azetidine (CAS 937609-13-7)
- Ethyl 6-oxo-6-(3-(pyrrolidin-1-ylmethyl)phenyl)hexanoate (CAS 898771-07-8)
- [3-31]-Semaglutide D (CAS C152H230N42O47)
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