Method for preparing a quality control mixture for glycine tablets
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United States of America Patent
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Dec 28, 2010
Grant Date -
May 14, 2009
app pub date -
Dec 15, 2006
filing date -
Dec 16, 2005
priority date (Note) -
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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 100:1 ratio of water to porphyrized tablets, each tablet containing 0.101 g microcapsules of non-agglomerated crystals of amino-acetic acid covered with polymeric film of water-soluble methylcellulose, each tablet further comprising 0.001 g magnesium stearate. The process of dissolution takes 20 minutes and is carried out at a temperature of 37.degree. C. in an apparatus using a paddle rotation speed of 150 revolutions per minute. After the mixture is dissolved, it is allowed to stand for 10 minutes, 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 range of 50% to 70% compared to purified water corresponds to the proper quality.
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