Thioctic Acid Impurity 8 CAS 1070-65-1
| CAS No. | 1070-65-1 |
| Molecular Formula | C10H19ClO3 |
| Molecular Weight | 222.71 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
Under current pharmacopoeial and regulatory frameworks, quality-control requirements for this class of reference material explicitly involve the control of targets including Thioctic Acid Impurity 8.
Thioctic Acid Impurity 8 (CAS 1070-65-1) is a certified pharmaceutical impurity reference standard with the molecular formula C10H19ClO3 and a molecular weight of 222.71 g/mol.
Thioctic Acid Impurity 8 (C10H19ClO3) contains a carboxylic acid group, a hydroxyl group, an ether linkage, chlorine substitution. It is notably hygroscopic, halogen substitution raises its density and boiling point, its high carbon-to-hydrogen ratio confers good lipid solubility, 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 | C10H19ClO3 |
| Molecular Weight | 222.71 g/mol |
| Purity | >95% |
| Storage | Store in a cool place (≤25°C), keep sealed and dry, keep tightly closed to prevent evaporation |
| Solubility (reference) | Soluble in methanol, ethanol, DMSO |
| Stability | Hygroscopic; reseal immediately after opening; Contains ester bond; hydrolyzes under strong alkaline conditions |
| Degree of Unsaturation (DBE) | 1.0 |
| CAS Registry Year (est.) | 1957 |
| Halogen Content | Cl-containing |
Related Thioctic Standards
- Thioctic acid Impurity 28 (CAS 947236-49-9)
- Thioctic acid Impurity 74 (CAS 852383-82-5)
- Thioctic acid Impurity 94 (CAS 50628-93-8)
- Thioctic acid Impurity 10 (CAS 188783-96-2)
- Thioctic acid Impurity 12 (CAS CATO-C4X-152612)
- Thioctic acid Impurity 2 (CAS 108015-78-7)
- Thioctic acid Impurity 20 (CAS 2114407-83-7)
- Thioctic acid Impurity 26 (CAS 2114407-76-8)
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