Bictegravir impurity 11 CAS CATO-C4X-218111
| CAS No. | CATO-C4X-218111 |
| Molecular Formula | C7H13NO2 |
| Molecular Weight | N/A |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
As a process- or degradation-related impurity, Bictegravir impurity 11 (CAS CATO-C4X-218111, C7H13NO2HCl) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
Bictegravir impurity 11 (C7H13NO2HCl) contains an amide group, a carboxylic acid group, a hydroxyl group, an ether linkage, chlorine substitution. 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. 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 | C7H13NO2 HCl |
| Molecular Weight | 179.64 g/mol |
| Purity | 97%+ |
| Storage | Store at 2-8°C, protect from light, keep tightly closed to prevent evaporation |
| Solubility (reference) | Soluble in methanol, acetonitrile, DMSO, water (slightly soluble) |
| Stability | Light-sensitive; avoid direct strong light; Contains ester bond; hydrolyzes under strong alkaline conditions |
| Degree of Unsaturation (DBE) | 1.0 |
| Halogen Content | Cl-containing |
| Nitrogen Atoms | 1 |
Related Bictegravir Standards
- Bictegravir Related Compound 2 (CAS 1110772-05-8)
- Bictegravir Impurity 7 (CAS 1284248-73-2)
- Bictegravir Related Compound C001/Dolutegravir Intermediate-1 (CAS 1335210-23-5)
- Bictegravir (CAS 1611493-60-7)
- Bictegravir sodium (CAS 1807988-02-8)
- Bictegravir-15N, d2 (CAS CATO-C4X-21811)
- Bictegravir Impurity 10(2R,5S,13aS) (CAS CATO-C4X-218110)
- Bictegravir Impurity 2 (CAS CATO-C4X-21812)
Recommended Standards
- Riociguat Impurity 38 (CAS CATO-C4X-174938)
- Crisaborole Impurity 64 (CAS 1160182-44-4)
- Regadenoson Impurity 26 (CAS 5404-87-5)
- tert-Butyl 3-formylthiophene-2-carboxylate (CAS 1379369-59-1)
- 5-(4-Fluoro-3-methylphenyl)thiazol-2-amine (CAS 886761-83-7)
- 3-[(5Z)-4-Oxo-5-(phenylmethylidene)-2-sulfanylidene-1,3-thiazolidin-3-yl]-3-azabicyclo[3.1.0]hexane-2,4-dione (CAS 866156-29-8)
- 3-Oxo-N-(3-oxobutanoyl)-N-(o-tolyl)butanamide (CAS 68912-00-5)
- Tert-butyl 1-(hydroxymethyl)-3,9-diazaspiro[5.5]Undecane-3-carboxylate (CAS 1706455-11-9)
- 4-Chloro-2,6-dimethoxybenzaldehyde (CAS 1476848-17-5)
- Insulin Degludec Impurity 3 (CAS CATO-C4X-21573)
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