Levothyroxine EP Impurity J CAS 4604-41-5
| CAS No. | 4604-41-5 |
| Molecular Formula | C15H13I2NO4 |
| Molecular Weight | 525.08 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
Compared with other compounds in its class, the molecular weight of 525.08 g/mol gives Levothyroxine EP Impurity J distinctive chromatographic separation conditions and mass-spectrometry parameter settings.
As a process- or degradation-related impurity, Levothyroxine EP Impurity J (CAS 4604-41-5, C15H13I2NO4) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
The molecular framework of Levothyroxine EP Impurity J (C15H13I2NO4) is characterized by a flavonoid core, an amide group, a hydroxyl group, an ether linkage, iodine substitution. In reversed-phase chromatography, its retention is governed primarily by the protonation state of its nitrogen-containing groups, which provides a practical basis for HPLC-UV/DAD or LC-MS method development. 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 | C15H13I2NO4 |
| Molecular Weight | 525.08 g/mol |
| Appearance | Pale yellow to yellow crystalline powder. (slight halide-like odor, low volatility) |
| Purity | 97%+ |
| Storage | Store at room temperature, 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) | 9.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 1958 |
| Halogen Content | I-containing |
| Nitrogen Atoms | 1 |
Related Levothyroxine Standards
- Levothyroxine Impurity 16 (CAS 4192-14-7)
- rac-Levothyroxine EP Impurity J (3,3'-DL-Diiodothyronine) (CAS 70-40-6)
- Levothyroxine EP Impurity E (CAS 1041-01-6)
- Levothyroxine Impurity 37 (CAS 94345-95-6)
- Levothyroxine Impurity 18 (CAS 1155-40-4)
- Levothyroxine Impurity 38 (CAS 1027-28-7)
- Levothyroxine Impurity 58 (CAS 176258-87-0)
- Levothyroxine Impurity 42 (CAS 4618-45-5)
Recommended Standards
- VTP 27999 (CAS 942142-51-0)
- 7-(5-((tert-Butyldiphenylsilyl)oxy)-2-chlorophenyl)-5-methylbenzo[e][1,2,4]triazin-3-amine (CAS 1245644-51-2)
- 4-(bis(4-Iodophenyl)amino)benzaldehyde (CAS 808758-81-8)
- 3,5-Diiodo-DL-thyronine (CAS 534-51-0)
- Betaxolol Impurity 6 (CAS 116209-55-3)
- Bupivacaine EP Impurity E (CAS 1330172-81-0)
- Mianserin EP Impurity D HCl (CAS 157994-98-4（free base）)
- Estradiol Impurity 54 (CAS 1743-60-8)
- (S)-2-Amino-N-isopropyl-N-(pyridin-4-ylmethyl)propanamide (CAS 1353996-08-3)
- 1-(3-Hydroxypyrrolidin-1-yl)-2-(m-tolyl)ethan-1-one (CAS 1344226-03-4)
- Methyl[(1-methylpyrrolidin-3-yl)methyl]amine dihydrochloride (CAS 1185042-30-1)
- 1-(4-Chlorobenzyl)-1h-imidazole-4-carboxylic acid (CAS 725234-31-1)
- L-Valine, N-acetyl-, 2,5-dioxo-1-pyrrolidinyl ester (CAS 56186-37-9)
- D-Ser32-Tirzepatide (CAS CATO-CPTD788677)
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