Glycopyrrolate Impurity 18 CAS CATO-C4X-143118
| CAS No. | CATO-C4X-143118 |
| Molecular Formula | C19H26NO3 |
| Molecular Weight | N/A |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
The occurrence of Glycopyrrolate Impurity 18 is closely related to a steroid core, an amide group, a hydroxyl group, an ether linkage, bromine substitution in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.
CATO supplies Glycopyrrolate Impurity 18 (CAS CATO-C4X-143118), a pharmacopoeial impurity reference standard (molecular formula C19H26NO3Br, MW 396.32 g/mol) used for the identification and quantification of trace impurities in APIs.
Structurally, Glycopyrrolate Impurity 18 (C19H26NO3Br) contains a steroid core, an amide group, a hydroxyl group, an ether linkage, bromine 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 396.32 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.
As a certified reference material (CRM), Glycopyrrolate Impurity 18 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 | C19H26NO3 Br |
| Molecular Weight | 396.32 g/mol |
| Appearance | Off-white to pale yellow crystalline powder. (slight halide-like odor) |
| Purity | >95% |
| Storage | Store at 2-8°C, protect from light, keep sealed and dry |
| 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) | 7.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| Halogen Content | Br-containing |
| Nitrogen Atoms | 1 |
Related Glycopyrrolate Standards
- Glycopyrrolate Impurity 8 (CAS 104641-59-0)
- Glycopyrrolate Impurity 9 (CAS 104641-60-3)
- Glycopyrrolate Impurity 6 (CAS 1202407-99-5)
- Glycopyrrolate Impurity 6 (CAS 126497-27-6)
- Glycopyrrolate Impurity N13 (CAS 129784-11-8)
- Glycopyrrolate Impurity 12 (CAS 131237-81-5)
- Glycopyrrolate Impurity 5 (CAS 1404453-63-9)
- Glycopyrrolate Impurity 16 (CAS 201667-20-1)
Recommended Standards
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- 2,4-Dichloro-N-(piperidin-3-yl)benzamide hydrochloride (CAS 1587195-15-0)
- Nepafenac Impurity 5(Amfenac) (CAS 51579-82-9)
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- 4-Chloro-6-(3,5-dimethyl-1H-pyrazol-1-yl)pyrimidine (CAS 52476-65-0)
- Semaglutide impurity 23 (CAS CATO-C4X-222623)
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