Hyoscyamine Impurity 16 CAS CATO-C4X-343716
| CAS No. | CATO-C4X-343716 |
| Molecular Formula | C17H21NO4 |
| Molecular Weight | N/A |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
As a certified reference material (CRM), Hyoscyamine Impurity 16 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.
As a process- or degradation-related impurity, Hyoscyamine Impurity 16 (CAS CATO-C4X-343716, C17H21NO4HCl) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
Structurally, Hyoscyamine Impurity 16 (C17H21NO4HCl) contains a flavonoid core, an amide group, a hydroxyl group, an ether linkage, chlorine substitution. The molecule exhibits a degree of unsaturation (DBE) of 7.0, corresponding to approximately 7 ring(s) or double-bond equivalent(s). With a molecular weight of 339.82 g/mol, it falls into the moderately-high-molecular-weight range. 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.
Physical & Chemical Properties
| Molecular Formula | C17H21NO4 HCl |
| Molecular Weight | 339.82 g/mol |
| Appearance | Off-white to pale yellow crystalline powder. (slight halide-like odor) |
| Purity | 97%+ |
| Storage | Store at 2-8°C, protect from light, keep sealed and dry |
| Solubility (reference) | Soluble in methanol, acetonitrile, DMSO, water (slightly soluble) |
| 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) | 7.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| Halogen Content | Cl-containing |
| Nitrogen Atoms | 1 |
Related Hyoscyamine Standards
- (-)-Hyoscyamine (CAS 101-31-5)
- Hyoscyamine Hydrobromide (CAS 306-03-6)
- Hyoscyamine EP Impurity E TFA Salt (CAS 537-29-1(free base))
- Hyoscyamine EP Impurity E Trifluoroacetate Salt (CAS 537-29-1（free base）)
- Hyoscyamine Hydrochloride - API Standards (CAS 5934-50-9)
- Hyoscyamine sulfate (CAS 620-61-1)
- Hyoscyamine Sulphate Hydrate (CAS 6835-16-1)
- Hyoscyamine Impurity 10 (CAS CATO-C4X-343710)
Recommended Standards
- Cilastatin Impurity 43 (CAS CATO-C4X-196043)
- Atropine Impurity 17 (CAS 16202-15-6)
- Beclometasone Impurity 43 (CAS CATO-C4X-147443)
- Methyl 2-(8-bromo-1,3-difluorophenanthren-2-yl)-2-fluoropropanoate (CAS 843614-92-6)
- Methylergometrine EP Impurity I Acetate (CAS 724767-21-9 (free base))
- 1-(Styrylsulfonyl)piperazine (CAS 222544-31-2)
- Tert-butyl 4-((R)-1-amino-2-methoxy-2-oxoethyl)-3,3-dimethylpiperidine-1-carboxylate (CAS 2387585-37-5)
- 4-Bromo-3-chloro-5-(difluoromethyl)picolinoyl chloride (CAS 1805162-59-7)
- (1H-Benzo[d][1,2,3]triazol-1-yl)(2-phenethylphenyl)methanone (CAS 776297-10-0)
- Hexapeptide-1 (CAS CATO-CPTD788821)
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