CasNo.443-69-6,5-Fluoroisatin,(443-69-6) Suppliers

1 Kilogram	FOB Price: USD 10.0000

Min.Order :1 Kilogram
Purity: 95%+
Payment Terms : T/T,Other

Keywords

5-fluoro-1H-indole-2,3-dione 1H-Indole-2,3-dione, 5-fluoro- 443-69-6

Quick Details

Appearance:off-white powder
Application:Pharmaceutical research
PackAge:Screw bottle,foil bags,Reagent bottles
ProductionCapacity:5000|Metric Ton|Year
Storage:cool and dry
Transportation: DHL,FedEx,UPS,EMS,TNT;

Superiority:

We supply over 20000 types of spot impurity reference materials, with sufficient supply and same day delivery to meet customers' urgent needs for replenishment at any time. The company has its own research and development center and laboratory, and the team members have over ten years of experience in developing drug impurity reference standards. Our website www.molcoo.com covers over 98% of cutting-edge generic drug projects, with complete structural formulas that greatly save customers time in impurity structure analysis and inference. All products undergo strict quality control testing and provide relevant information such as COA, H-NMR, C-NMR, MS/GC-MS, HPLC/GC purity, QNMR quantification, TGA thermogravimetric analysis, IR infrared, UV ultraviolet, two-dimensional (COSY, NOESY, HMBC, HMQC), etc. These structural confirmation spectra ensure quality and reliability. Our products have a wide range of categories, fast delivery time, good quality, and low prices, which can quickly solve various customer needs such as replenishment and consistency evaluation.

Details:

Product Information

Product Code：F016008
English Name：Flumazenil Impurity 8
English Alias：5-fluoroindoline-2,3-dione
CAS No.：443-69-6
Molecular Formula：C?H?FNO?
Molecular Weight：165.12

Advantages

High-Purity Reference Standard：Confirmed by HPLC (≥99.0%), NMR (1H, 13C), HRMS, and elemental analysis, suitable for Flumazenil impurity analysis and quality control.
Stability Assurance：Stable for 36 months at -20℃ under light-protected, sealed storage; degradation rate <0.3% in acetonitrile-water solution within 6 months.

Applications

Quality Control Testing：Used for UPLC-MS/MS detection of Impurity 8 in Flumazenil API and formulations, controlling content to meet ICH Q3A standards (single impurity limit ≤0.1%).
Process Optimization Research：Monitors Impurity 8 formation during Flumazenil synthesis, reducing generation by >40% by adjusting fluorination temperature (e.g., 50-60℃) and reaction time.
Method Validation：Serves as a standard for developing impurity detection methods, verifying UPLC resolution (≥3.0) and LOD (0.01 ng/mL).

Background Description

Flumazenil, a benzodiazepine receptor antagonist, is used to reverse central inhibition by benzodiazepines. Impurity 8, as a process-related impurity of Flumazenil, may originate from side products of indole ring fluorination and oxidation during synthesis. Its fluorine atom and dione groups may affect drug stability and efficacy. With stricter FDA and EMA requirements for CNS drug impurities, studying Impurity 8 is crucial for ensuring drug quality.

Research Status

Detection Technology：UPLC-MS/MS with C18 column (1.7μm) and 0.1% formic acid-acetonitrile gradient elution achieves separation within 4 minutes, with LOD of 0.005 ng/mL for trace impurity analysis.
Formation Mechanism：Formed by fluorination of indoline-2,3-dione with fluorinating agents (e.g., Selectfluor); optimizing fluorinating agent dosage and reaction solvent polarity (e.g., DMF instead of dichloromethane) inhibits side reactions.
Safety Evaluation：In vitro cytotoxicity shows IC?? of 185.6 μM against SH-SY5Y cells (Flumazenil IC??=15.2 μM), with lower toxicity than the main drug but requiring strict content control. Long-term stability testing is ongoing to monitor degradation under different humidity, light, and temperature conditions.