Aniracetam CAS 72432-10-1 Assay 98.0~101.0%

Melting Point
The melting point of this product (General rule 0612) is 118-122℃.
Absorption Coefficient
Take an appropriate amount of this product and weigh it accurately, add anhydrous ethanol to dissolve and quantitatively dilute to prepare a solution containing about 10μg per lml, according to ultraviolet-visible spectrophotometry (General rule 0401), the absorbance was measured at a wavelength of 282nm, and the absorption coefficient was 476 to 506.
Differential diagnosis
1. Take about 50mg of this product, put it in a test tube, add 2ml sulfuric acid to dissolve, the solution is pale yellow, add 2ml water, add several drops of sodium nitrite solution, shake for 10~15 minutes, generate white precipitate.
2. The infrared absorption spectrum of this product should be consistent with that of the control (Spectrum set 769).
Exam
Related Substances
Take about 10 mg of this product, add mobile phase to dissolve and dilute to make a solution containing 1 mg per 1 ml, as a test solution; Take appropriate amount with precision, A solution containing 2μg per 1 ml was prepared as a control solution by quantitative dilution with mobile phase. The detection wavelength was 254nm according to the chromatographic conditions under the content measurement. Take 10μl of the test solution and the control solution respectively, inject the human liquid chromatograph, record the chromatogram to 4 times of the retention time of the main component peak. If there are impurity peaks in the chromatogram of the test solution, the area of a single impurity peak shall not be greater than the area of the main peak of the control solution (0.2%) , the sum of each impurity peak area shall not be greater than 5 times (1.0%) of the main peak area of the control solution.
Residual solvent
Take about 0.1g of this product, weigh it accurately, put it in a 20ml headspace bottle, add 1ml of N,N-dimethylformamide to dissolve it, seal it, shake it well, and use it as a test solution; respectively take the appropriate amount of ethanol, toluene, precision weighing, plus N,N-dimethylformamide quantitative dilution into each lml respectively containing ethanol 500μg, toluene 89μg solution, precision take 1ml, A 20ml headspace bottle was placed, sealed, and used as a control solution. According to the determination method of residual solvent (General Principle 0861 second method), the capillary column with 6% cyanopropyl phenyl-94% dimethyl polysiloxane as stationary liquid (or similar polarity) is the column; The initial temperature is 40℃, hold for 5 minutes, ramp to 160℃ at a rate of 20℃ per minute for 5 minutes at a detector temperature of 240°C. The inlet temperature was 220℃; The headspace bottle equilibration temperature was 100℃ and the equilibration time was 30 minutes. Take the reference solution into the headspace, record the chromatogram, and the separation degree between the ethanol peak and the toluene peak should meet the requirements. The test solution and the reference solution were injected by Headspace, and the chromatograms were recorded. According to the external standard method to calculate the peak area, the residual amount of ethanol and toluene should be in accordance with the provisions.
Loss on Drying
taking this product, using phosphorus pentoxide as desiccant, drying under reduced pressure at 60℃ for 4 hours, the weight loss shall not exceed 0.5% (General rule 0831).
Ignition Residue
take 1.0g of this product and check it according to law (General rule 0841). The residue left shall not exceed 0.1%.
Heavy Metals
Take the residue left by the ignition residue item, check according to law (General Principles 0821 second law), containing heavy metals shall not exceed 10 parts per million.