Chlorhexidine EP Impurity M 2HCl CAS CATO-C4X-225611
| CAS No. | CATO-C4X-225611 |
| Molecular Formula | C22H31ClN10 |
| Molecular Weight | N/A |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
Compared with other compounds in its class, the molecular weight of 507.47 g/mol gives Chlorhexidine EP Impurity M 2HCl distinctive chromatographic separation conditions and mass-spectrometry parameter settings.
As a process- or degradation-related impurity, Chlorhexidine EP Impurity M 2HCl (CAS CATO-C4X-225611, C22H31ClN10HCl) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
Structurally, Chlorhexidine EP Impurity M 2HCl (C22H31ClN10HCl) contains a nitrogen-containing heterocyclic scaffold, a nitrile group, chlorine substitution. The molecule exhibits a degree of unsaturation (DBE) of 11.0, corresponding to approximately 11 ring(s) or double-bond equivalent(s). With a molecular weight of 507.47 g/mol, it falls into the moderately-high-molecular-weight range. 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.
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 | C22H31ClN10 2*HCl |
| Molecular Weight | 507.47 g/mol |
| Appearance | Pale yellow to yellow crystalline powder. (slight halide-like odor, low volatility) |
| Purity | >95% |
| Storage | Store at room temperature, protect from light |
| Solubility (reference) | Soluble in DMSO, DMF, methanol |
| Stability | May oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light |
| Degree of Unsaturation (DBE) | 11.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| Halogen Content | Cl-containing |
| Nitrogen Atoms | 10 |
Related Chlorhexidine Standards
- Chlorhexidine-d8 Dihydrochloride (CAS 1246816-96-5)
- Chlorhexidine Diacetate EP Impurity B (CAS 1308292-89-8)
- Chlorhexidine EP Impurity K HCI (CAS 1381962-77-1（free base）)
- Chlorhexidine EP Impurity A (CAS 152504-08-0)
- Chlorhexidine EP Impurity A Hydrochloride (CAS 152504-08-0（free base）)
- Chlorhexidine Digluconate EP Impurity G HCl (CAS 152504-09-1 (free base))
- Chlorhexidine EP Impurity N (CAS 152504-10-4)
- Chlorhexidine Diacetate Impurity 2 Hydrochloride (CAS 152504-10-4(Free Base))
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