Dolutegravir O-Methyl Impurity CAS 1335210-35-9
| CAS No. | 1335210-35-9 |
| Molecular Formula | C21H21F2N3O5 |
| Molecular Weight | 433.41 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
CATO supplies Dolutegravir O-Methyl Impurity (CAS 1335210-35-9), a pharmacopoeial impurity reference standard (molecular formula C21H21F2N3O5, MW 433.41 g/mol) used for the identification and quantification of trace impurities in APIs.
Dolutegravir O-Methyl Impurity (C21H21F2N3O5) contains a flavonoid core, an amide group, a hydroxyl group, an ether linkage, fluorine substitution. It is notably hygroscopic, halogen substitution raises its density and boiling point, the carboxyl group imparts weak acidity; these physicochemical properties determine the optimal preparation and storage of its standard solutions. 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 | C21H21F2N3O5 |
| Molecular Weight | 433.41 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) | 12.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 1991 |
| Halogen Content | F-containing |
| Nitrogen Atoms | 3 |
Related Dolutegravir Standards
- Dolutegravir Impurity 15 (CAS 2384108-28-3)
- Dolutegravir Impurity 34 (CAS 2227442-13-7)
- Dolutegravir Impurity 35 (CAS 2583719-57-5)
- Dolutegravir Impurity 42 (CAS CATO-C4X-162042)
- Dolutegravir Impurity 58 (CAS 2244245-35-8)
- Dolutegravir Impurity 69 (CAS CATO-C4X-162069)
- Dolutegravir Impurity 62 (CAS CATO-C4X-162062)
- Dolutegravir M3 (CAS 1485692-24-7)
Recommended Standards
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- 6-(Benzylamino)-5-methylnicotinonitrile (CAS 1355225-10-3)
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- Steroidogenesis-Activator Polypeptide (rat) (H-8855.0500) (CAS 108563-23-1)
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