Fluphenazine Decanoate EP Impurity D CAS 97671-70-0
| CAS No. | 97671-70-0 |
| Molecular Formula | C30H40F3N3O2S |
| Molecular Weight | 563.72 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 Fluphenazine Decanoate EP Impurity D.
CATO supplies Fluphenazine Decanoate EP Impurity D (CAS 97671-70-0), a pharmacopoeial impurity reference standard (molecular formula C30H40F3N3O2S, MW 563.72 g/mol) used for the identification and quantification of trace impurities in APIs.
Fluphenazine Decanoate EP Impurity D (C30H40F3N3O2S) contains a steroid core, an amide group, a sulfone 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. 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 | C30H40F3N3O2S |
| Molecular Weight | 563.72 g/mol |
| Purity | 97%+ |
| 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) | 11.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 1984 |
| Halogen Content | F-containing |
| Nitrogen Atoms | 3 |
| Sulfur Atoms | 1 |
Related Fluphenazine Standards
- Fluphenazine Decanoate EP Impurity E (CAS CATO-C4X-12314)
- Fluphenazine Enanthate (CAS 2746-81-8)
- Fluphenazine Decanoate EP Impurity F (CAS 13220-06-9)
- Fluphenazine Decanoate N-Oxide (CAS 76005-64-6)
- Fluphenazine Decanoate N-oxide-1 (CAS 76013-31-5)
- Fluphenazine β-D-Glucuronide (CAS 133310-09-5)
- Fluphenazine Decanoate EP Impurity G (CAS 61555-18-8)
- Fluphenazine EP Impurity B (CAS 1476-79-5)
Recommended Standards
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- 1-Isopropyl-1H-pyrazole-5-carbonyl Chloride (CAS 1076245-75-4)
- Ethyl 10-fluoro-7-thia-2,5-diazatricyclo[6.4.0.0^{2,6}]dodeca-1(8),3,5,9,11-pentaene-4-carboxylate (CAS 181486-57-7)
- n-Cyclopropyl-n-(pyrrolidin-2-ylmethyl)acetamide (CAS 1353972-12-9)
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- (D-Trp32)-Neuropeptide Y (porcine) trifluoroacetate salt (CAS 153549-78-1)
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