Method for preparing a quality control mixture for glycine...

Chemistry: analytical and immunological testing – Peptide – protein or amino acid – Amino acid or sequencing procedure

Reexamination Certificate

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C514S561000

Reexamination Certificate

active

07858377

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° 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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patent: 5731349 (1998-03-01), Komissarova et al.
patent: 2004/0029966 (2004-02-01), Komissarova
Ahmed et al. (“Quality of Marketed Metronidazole Preparations in Bangladesh—An Analytical Overview,” J. Biol. Sci. 2003, 3, 940-950).

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