Abstract: A method is described for preparing a mixture for quality control of 0.1 g glycine tablets for sublingual application. The mixture for quality control includes a 100:0.5 ratio of ethanol to porphyrized tablets, each tablet containing 0.1 g microcapsules of non-agglomerated crystals of amino-acetic acid covered with a polymeric film of water-soluble methylcellulose, each tablet further containing 0.001 g of magnesium stearate. The process for preparing the mixture includes dissolution of the tablet in ethanol for 20 minutes and is carried out at a temperature of 40° C. in an apparatus using a paddle rotation speed of 200 revolutions per minute. After the mixture is dissolved, it is allowed to stand for 10 minutes at room temperature, and then a light transmission coefficient is measured at 700±2 nm for a 10 mm thick layer of the mixture. A transmission value within the limits of 90% to 100% compared with 50% ethanol corresponds to the proper quality.

Abstract: The invention relates to the chemical-pharmaceutical industry and specifically to mix for identification test in the process of quality control of the medicine ‘Glycine tablets for sublingual applying 0.1 g.’ its preparation method and method of identity evaluation in the process of quality control of the mentioned medicine. There is prepared mix containing 50% etha??l and porphyrized tablets in a ratio 100:0.5. The method involves dissolution of 1.25 g of porphyrized tablets in 250 ml of 50% ethanol. Process of dissolution takes 20 minutes and is carried out at a temperature of 400 C in the apparatus for dissolving determination at a paddle rotation speed of 200 rpm. After mix is dissolved it is allowed for 10 minutes RT. Method of identification test includes hydro-alcohol mix preparation using 50% ethanol as described before. Then there are selected 4 ml of the mix for light transmission spectrophotometer analysis at a wave length of 700±2 in a cuvet with layer thickness of 10 mm relative to 50% ethanol.