Meclofenoxate Hydrochloride CAS 3685-84-5 Assay >99.0% (HPLC) Nootropic

Acidity
Take 0.20g of this product and add 20ml of water to dissolve. The pH value should be 3.5~4.5 (General rule 0631).
Clarity of the solution
Take 1.0g of this product, add 10ml of water to dissolve, the solution should be clarified. (For injection)
Sulfate
Take 1.0g of this product and check it according to law (General rule 0802). Compared with the control solution made of 4.8ml of standard potassium sulfate solution, it should not be more concentrated (0.048%).
Organic Acids
Take this product 2.0g, add ether 50ml, shake for 10 minutes. Filter with G3 vertical melting funnel, the residue is washed with diethyl ether 2 times, each time 5ml, wash and filtrate, add neutral ethanol 50ml and phenolphthalein indicator solution 5 drops, with sodium hydroxide titration solution (0.1mol/L) titration, consumption of sodium hydroxide titration solution (0.1mol/L) not over 0.54.
Related Substances
New system for clinical use. Take about 50mg of this product, weigh it accurately, put it in a 50ml measuring flask, add an appropriate amount of solvent [water (adjust pH to 2.5 with phosphoric acid)-acetonitrile (4060)], shake to dissolve, and diluted to the scale, shake, as a test solution; Precision take 1ml, 100ml flask, diluted with the above solvent to the scale, shake, as a control solution. Test according to high performance liquid chromatography (General 0512). Silica gel bonded with eighteen alkyl silane was used as the filler, and 0.05mol/L sodium octane sulfonate (adjusted to pH 2.5 with phosphoric acid)-acetonitrile (65:35) was used as the mobile phase, and the detection wavelength was 225nm. Take about 10mg of this product, put it in a 10ml measuring flask, add 4ml of water to dissolve, heat it in a water bath for 5 minutes, dilute it with acetonitrile to the scale, shake well, and inject l0ul into the liquid chromatograph, the degree of separation of the meclofenoxate peak from the hydrolysis product peak (relative retention time about 0.6) should be greater than 6.0.1 Ou1 of the test solution and the control solution were respectively injected into the liquid chromatograph, and the chromatogram was recorded to 2 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 0.5 times (0.5%) the area of the main peak of the control solution, and the sum of the areas of each impurity peak shall not be greater than the area of the main peak of the control solution (1.0%).
Loss on Drying
Take this product, dry to constant weight at 105℃, weight loss should not exceed 1.0% (for oral use) or 0.5% (for injection) (General 0831).
Ignition Residue
Not more than 0.1% (General rule 0841).
Heavy Metals
Take 1.0g of this product, add 23ml of water to dissolve, add 2ml of acetate buffer (pH 3.5), and check according to law (General rule 0821 first law), containing heavy metals shall not exceed 10 parts per million.