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CAS NO.5447-86-9
1(10.0-10000)Milligram
Advantages (M093001)
High-Purity Reference Standard:Confirmed by HPLC (≥99.0%), NMR (1H, 13C), HRMS, and elemental analysis, suitable for Melitracen impurity analysis and quality control.
Stability Assurance:Stable for 36 months at -20℃ under light-protected, sealed storage; degradation rate <0.3% in common solvents like methanol and acetonitrile within 6 months.
Melitracen Impurity;5447-86-9
Product Information (M093001)
Product Code:M093001
English Name:Melitracen Impurity 1
English Alias:10,10-dimethylanthracen-9(10H)-one
CAS No.:5447-86-9
Molecular Formula:CHO
Molecular Weight:222.28
Advantages (M093001)
High-Purity Reference Standard:Confirmed by HPLC (≥99.0%), NMR (1H, 13C), HRMS, and elemental analysis, suitable for Melitracen impurity analysis and quality control.
Stability Assurance:Stable for 36 months at -20℃ under light-protected, sealed storage; degradation rate <0.3% in common solvents like methanol and acetonitrile within 6 months.
Applications (M093001)
Quality Control Testing:Used for UPLC-MS/MS detection of Impurity 1 in Melitracen API and formulations, controlling content to meet ICH Q3A standards (single impurity limit ≤0.1%).
Process Optimization Research:Monitors impurity formation during Melitracen synthesis, reducing generation by >30% by adjusting condensation temperature (e.g., 60-70℃) and catalyst dosage.
Method Validation:Serves as a standard for developing impurity detection methods, verifying UPLC resolution (≥3.0) and LOD (0.01 ng/mL).
Background Description (M093001)
Melitracen, a tricyclic antidepressant, is used for treating anxiety and depressive disorders. Impurity 1, a process-related impurity in its synthesis, may originate from anthracene ring construction or methylation side reactions. Its methyl and anthrone groups may affect drug lipophilicity, stability, and efficacy. With strict impurity control requirements for psychiatric drugs, studying this impurity is crucial for ensuring drug quality.
Research Status (M093001)
Detection Technology:UPLC-MS/MS with C18 column (1.7μm) and 0.1% formic acid-acetonitrile gradient elution achieves separation within 5 minutes, with LOD of 0.003 ng/mL for high-precision trace impurity analysis.
Formation Mechanism:Formed by oxidation of 10,10-dimethylanthracene with oxidants (e.g., manganese dioxide); optimizing oxidant dosage and reaction time reduces by-product generation.
Safety Evaluation:In vitro cytotoxicity shows IC of 205.6 μM against SH-SY5Y cells (Melitracen IC=11.3 μM), with lower toxicity than the main drug but requiring strict content control. Long-term stability testing is ongoing to monitor degradation under light and high-temperature conditions.