Glycopyrrolate Impurity 9 CAS CATO-C4X-14319
| CAS No. | CATO-C4X-14319 |
| Molecular Formula | C19H26NO3 |
| Molecular Weight | N/A |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
The occurrence of Glycopyrrolate Impurity 9 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.
Glycopyrrolate Impurity 9 (CAS CATO-C4X-14319) is a certified pharmaceutical impurity reference standard with the molecular formula C19H26NO3Br and a molecular weight of 396.32 g/mol.
Structurally, Glycopyrrolate Impurity 9 (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 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.
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 | 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
- Ornidazole Impurity 86 (CAS CATO-C4X-133186)
- Josamycin EP Impurity I (CAS 18361-47-2)
- Paliperidone Impurity 31 (CAS 1172995-11-7)
- Benzo[e]isatin (CAS 5588-87-4)
- 1-(3-Bromopropyl)-4-methylcyclohexane (CAS 2808-51-7)
- 4-Iodo-N-(2-methylbut-3-yn-2-yl)benzenesulfonamide (CAS 1009101-88-5)
- 2-(Chloromethyl)-1,4,5,6-tetrahydropyrimidine hydrochloride (CAS 79983-34-9)
- 4,5-Dibromo-2-ethyl-1H-imidazole (CAS 4002-82-8)
- 3-Ethyl-4-fluorophenylboronic acid (CAS 960235-01-2)
- GnRH Associated Peptide (GAP) (1-13), human (CAS 100111-07-7)
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