Miconazole EP Impurity I CAS 24169-00-4
| CAS No. | 24169-00-4 |
| Molecular Formula | C18H15Cl3N2O |
| Molecular Weight | N/A |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
The occurrence of Miconazole EP Impurity I is closely related to a flavonoid core, an amide group, a hydroxyl group, an ether linkage, chlorine substitution in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.
CATO supplies Miconazole EP Impurity I (CAS 24169-00-4), a pharmacopoeial impurity reference standard (molecular formula C18H15Cl3N2OHNO3, MW 444.69 g/mol) used for the identification and quantification of trace impurities in APIs.
Based on its molecular formula C18H15Cl3N2OHNO3, Miconazole EP Impurity I contains a flavonoid core, an amide group, a hydroxyl group, an ether linkage, chlorine substitution; these features give the compound characteristic absorption bands in UV spectroscopy. The molecular weight of 444.69 g/mol is directly relevant to the identification of the molecular ion in mass spectrometry. 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.
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 | C18H15Cl3N2O HNO3 |
| Molecular Weight | 444.69 g/mol |
| Appearance | Pale yellow to yellow crystalline powder. (slight halide-like odor, low volatility) |
| Purity | >95% |
| Storage | Store in a cool place (≤25°C), protect from light, keep sealed and dry |
| Solubility (reference) | Soluble in DMSO, DMF, methanol |
| Stability | May oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light; Hygroscopic; reseal immediately after opening; Contains ester bond; hydrolyzes under strong alkaline conditions |
| Degree of Unsaturation (DBE) | 11.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 1963 |
| Halogen Content | Cl-containing |
| Nitrogen Atoms | 3 |
Related Miconazole Standards
- Miconazole-d5 Nitrate (CAS 1216653-51-8)
- Miconazole EP Impurity H (CAS 181931-30-6)
- Miconazole EP Impurity H (CAS 181931-30-6（free base）)
- Miconazole Impurity H nitarte salt (CAS 203264-09-9)
- Miconazole Nitrate (CAS 228321-87-7)
- Miconazole (CAS 22916-47-8)
- Miconazole EP Impurity D (CAS 24168-96-5)
- Miconazole EP Impurity B (CAS 24169-02-6)
Recommended Standards
- Rosuvastatin Impurity 77 (CAS 615556-96-2)
- Ciclosporin EP Impurity D (CAS 108027-45-8)
- Thiamphenicol Impurity 7 HCl (CAS CATO-C4X-20477)
- Methyl 4-iodo-1H-indole-6-carboxylate (CAS 597562-19-1)
- 8-Fluoro-6-methylquinoline-3-carboxylic acid (CAS 1602823-79-9)
- 1,5-Naphthalenedisulfonic acid sodium salt (CAS 1655-29-4)
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- 2-(Chloromethyl)-6-methylthieno[2,3-d]pyrimidin-4-ol (CAS 878699-59-3)
- 8-Iodo-naphthalen-2-ol (CAS 29921-51-5)
- Semaglutide-d8 Tetratrifluoroacetate (CAS CATO-C4X-222617)
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