Dronedarone Impurity 55 CAS 100-07-2
| CAS No. | 100-07-2 |
| Molecular Formula | C8H7ClO2 |
| Molecular Weight | 170.59 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
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.
CATO supplies Dronedarone Impurity 55 (CAS 100-07-2), a pharmacopoeial impurity reference standard (molecular formula C8H7ClO2, MW 170.59 g/mol) used for the identification and quantification of trace impurities in APIs.
Owing to a carboxylic acid group, a hydroxyl group, an ether linkage, chlorine substitution, an aromatic ring system, Dronedarone Impurity 55 is typically off-white to pale yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 170.59 g/mol — guide the selection of appropriate sample preparation and analytical techniques. The aromatic system may exhibit native fluorescence, enabling detection with a fluorescence detector (FLD).
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 | C8H7ClO2 |
| Molecular Weight | 170.59 g/mol |
| Appearance | Off-white to pale yellow crystalline powder. (slight halide-like odor) |
| Purity | 97%+ |
| Storage | Store at 2-8°C, keep tightly closed to prevent evaporation |
| Solubility (reference) | Soluble in methanol, acetonitrile, DMSO, water (slightly soluble) |
| Stability | May oxidize slowly on prolonged air exposure; Contains ester bond; hydrolyzes under strong alkaline conditions |
| Degree of Unsaturation (DBE) | 5.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 1957 |
| Halogen Content | Cl-containing |
Related Dronedarone Standards
- Dronedarone Impurity 75 (CAS 2003093-69-2)
- Dronedarone Impurity 73 (CAS 5337-04-2)
- Dronedarone Impurity 62 (CAS 5511-89-7)
- Dronedarone Impurity 74 (CAS 948015-51-8)
- Dronedarone Impurity 56 (CAS 28141-24-4)
- Dronedarone Impurity 63 (CAS 90050-13-8)
- Dronedarone Impurity 59 (CAS 13422-90-7)
- Dronedarone Impurity 61 (CAS 1343091-70-2)
Recommended Standards
- Tadalafil Impurity 101 (CAS 20850-43-5)
- Decitabine Impurity 28 (CAS 1126-46-1)
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- Azelastine Impurity 34 (CAS 1878-66-6)
- Losartan Impurity 37 (CAS CATO-C4X-168337)
- Betamethasone Impurity 80 (CAS 25092-10-8)
- Ixazomib Impurity 74 (CAS CATO-C4X-126774)
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- 2-(Benzyloxy)cyclobutan-1-amine (CAS 1824515-71-0)
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- (R)-2-(3-Hydroxypyrrolidin-1-yl)isonicotinonitrile (CAS 1379441-05-0)
- [Ser]8-Acetylated Semaglutide (CAS CATO-C4X-2226218)
Why CATO?
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